Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Asthma Clinical Trial

Official title:

A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350207
• Other study ID #: 205.342
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2006
• Last updated: November 27, 2013
• Start date: July 2006

Study information

• Verified date: September 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: French Health Products Safety Agency (AFSSAPS)Germany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAGreece: EOF-National Organisation for MedicinesItaly: Committee for the clinical experimentation of drug - Company Hospital University PisanaRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Medicines and Healthcare Products AgencyTurkey: Ministry of Health Central Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion_Criteria:

1. Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)

2. All patients must sign and date an Informed Consent Form for the study prior to participation in the trial

3. Male or female outpatients with at least 18 years of age, but not older than 65 years

4. Patients must have a documented history of asthma

5. Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years

6. Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent

Exclusion_Criteria:

1. Patients with a significant disease other than asthma

2. Patients with a recent history (i.e., six months or less) of myocardial infarction

3. Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year

4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year

5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.

6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)

7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis

8. Patients with known active tuberculosis

9. Patients who have undergone thoracotomy with pulmonary resection.

10. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Tiotropium bromide

• Placebo

• Salmeterol xinafoate

Locations

Country	Name	City	State
Austria	205.342.43002 Boehringer Ingelheim Investigational Site	Graz
Austria	205.342.43004 Boehringer Ingelheim Investigational Site	Trofaiach
Austria	205.342.43003 Boehringer Ingelheim Investigational Site	Wels
Austria	205.342.43001 Boehringer Ingelheim Investigational Site	Wien
Austria	205.342.43005 Boehringer Ingelheim Investigational Site	Wien
Austria	205.342.43006 Boehringer Ingelheim Investigational Site	Wien
Austria	205.342.43007 Boehringer Ingelheim Investigational Site	Wien
Belgium	205.342.32010 Boehringer Ingelheim Investigational Site	Anderlecht
Belgium	205.342.32005 Boehringer Ingelheim Investigational Site	Angleur
Belgium	205.342.32002 Boehringer Ingelheim Investigational Site	Brussel
Belgium	205.342.32007 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	205.342.32014 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	205.342.32001 Boehringer Ingelheim Investigational Site	Gent
Belgium	205.342.32003 Boehringer Ingelheim Investigational Site	Herentals
Belgium	205.342.32004 Boehringer Ingelheim Investigational Site	Malmédy
Belgium	205.342.32012 Boehringer Ingelheim Investigational Site	Menen
Belgium	205.342.32006 Boehringer Ingelheim Investigational Site	Montigny-le-Tilleul
Belgium	205.342.32009 Boehringer Ingelheim Investigational Site	Namur
Belgium	205.342.32011 Boehringer Ingelheim Investigational Site	Turnhout
Belgium	205.342.32013 Boehringer Ingelheim Investigational Site	Yvoir
Denmark	205.342.45003 Boehringer Ingelheim Investigational Site	Aalborg
Denmark	205.342.45001 Boehringer Ingelheim Investigational Site	Hvidovre
Denmark	205.342.45002 Boehringer Ingelheim Investigational Site	Kobenhavn NV
Denmark	205.342.45004 Boehringer Ingelheim Investigational Site	Odense C
Finland	205.342.35803 Boehringer Ingelheim Investigational Site	Helsinki
Finland	205.342.35801 Boehringer Ingelheim Investigational Site	Jyväskylä
Finland	205.342.35802 Boehringer Ingelheim Investigational Site	Lahti
Finland	205.342.35804 Boehringer Ingelheim Investigational Site	Tampere
France	205.342.3305A Centre Hosp de la Cavale Blanche	Brest
France	205.342.3304A Cabinet Médical	Chamalières
France	205.342.3307A Boehringer Ingelheim Investigational Site	Chauny
France	205.342.3301A UCP-X - Clinique Médicale	Grenoble
France	205.342.3302A Hôpital Arnaud de Villeneuve	Montpellier
France	205.342.3306A Mediscis	Poitiers
France	205.342.3308A Boehringer Ingelheim Investigational Site	Saint Pierre la Réunion
France	205.342.3308B Boehringer Ingelheim Investigational Site	Saint Pierre la Réunion
Germany	205.342.49016 Boehringer Ingelheim Investigational Site	Beelitz-Heilstätten
Germany	205.342.49004 Boehringer Ingelheim Investigational Site	Berlin
Germany	205.342.49006 Boehringer Ingelheim Investigational Site	Berlin
Germany	205.342.49013 Boehringer Ingelheim Investigational Site	Berlin
Germany	205.342.49003 Boehringer Ingelheim Investigational Site	Bruchsal
Germany	205.342.49011 Boehringer Ingelheim Investigational Site	Frankfurt/Main
Germany	205.342.49007 Boehringer Ingelheim Investigational Site	Kassel
Germany	205.342.49009 Boehringer Ingelheim Investigational Site	Köln
Germany	205.342.49010 Boehringer Ingelheim Investigational Site	Mainz
Germany	205.342.49008 Boehringer Ingelheim Investigational Site	Minden
Germany	205.342.49015 Boehringer Ingelheim Investigational Site	Neuruppin
Germany	205.342.49012 Boehringer Ingelheim Investigational Site	Rathenow
Germany	205.342.49005 Boehringer Ingelheim Investigational Site	Rüdersdorf
Germany	205.342.49002 Boehringer Ingelheim Investigational Site	Weinheim
Greece	205.342.30001 Boehringer Ingelheim Investigational Site	Athens
Greece	205.342.30002 Boehringer Ingelheim Investigational Site	Athens
Greece	205.342.30005 Boehringer Ingelheim Investigational Site	Heraklion
Greece	205.342.30006 Boehringer Ingelheim Investigational Site	Kavala
Greece	205.342.30004 Boehringer Ingelheim Investigational Site	Larisa
Greece	205.342.30003 Boehringer Ingelheim Investigational Site	Thessaloniki
Italy	205.342.39003 Azienda Ospedaliera " S. Anna"	Ferrara
Italy	205.342.39006 Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	205.342.39005 Ospedale San Martino	Genova
Italy	205.342.39002 Università di Modena e Reggio Emilia	Modena
Italy	205.342.39010 Boehringer Ingelheim Investigational Site	Orbassano (to)
Italy	205.342.39007 Policlinico San Matteo	Pavia
Italy	205.342.39001 Ospedale di Cisanello	Pisa
Italy	205.342.39009 Boehringer Ingelheim Investigational Site	Sesto San Giovanni (mi)
Russian Federation	205.342.07001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.342.07002 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.342.07003 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.342.07004 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.342.07005 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.342.07006 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	205.342.07007 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	205.342.07008 Boehringer Ingelheim Investigational Site	St. Petersburg
Slovakia	205.342.42101 Boehringer Ingelheim Investigational Site	Banska Bystrica
Slovakia	205.342.42102 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	205.342.42104 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	205.342.42105 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	205.342.42107 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	205.342.42103 Boehringer Ingelheim Investigational Site	Kosice
Slovakia	205.342.42106 Boehringer Ingelheim Investigational Site	Trencin
Slovakia	205.342.42108 Boehringer Ingelheim Investigational Site	Zilina
South Africa	205.342.27002 Boehringer Ingelheim Investigational Site	Bellville
South Africa	205.342.27008 Boehringer Ingelheim Investigational Site	Bloemfontein
South Africa	205.342.27001 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	205.342.27004 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	205.342.27006 Boehringer Ingelheim Investigational Site	Centurion
South Africa	205.342.27003 Boehringer Ingelheim Investigational Site	Durban
South Africa	205.342.27007 Boehringer Ingelheim Investigational Site	George
South Africa	205.342.27005 Boehringer Ingelheim Investigational Site	Pretoria
Spain	205.342.34006 Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	205.342.34011 Boehringer Ingelheim Investigational Site	Centelles
Spain	205.342.34004 Hospital General Universitario de Guadalajara	Guadalajara
Spain	205.342.34002 Hospital de Gran Canaria Dr. Negrín	Las Palmas de Gran Canaria
Spain	205.342.34007 Hospital Universitari Arnau de Vilanova	Lleida
Spain	205.342.34003 Hospital Universitario La Paz	Madrid
Spain	205.342.34009 Hospital Universio Puerta del Hierro	Madrid
Spain	205.342.34008 Hospital Universitario Marqués de Valdecilla	Santander
Spain	205.342.34005 Hospital Vírgen de la Macarena	Sevilla
Spain	205.342.34010 Hospital General Universitario de Valencia	Valencia
Turkey	205.342.90001 Boehringer Ingelheim Investigational Site	Ankara
Turkey	205.342.90006 Boehringer Ingelheim Investigational Site	Ankara
Turkey	205.342.90003 Boehringer Ingelheim Investigational Site	Bursa
Turkey	205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul
Turkey	205.342.90005 Kocaeli Universitesi Tip Fakultesi	Izmit
Turkey	205.342.90004 Celal Bayar Universitesi Tip Fakultesi	Manisa
United Kingdom	205.342.44002 Boehringer Ingelheim Investigational Site	Aylesbury
United Kingdom	205.342.44001 Boehringer Ingelheim Investigational Site	Chertsey
United Kingdom	205.342.44003 Boehringer Ingelheim Investigational Site	Greenisland
United Kingdom	205.342.44006 Boehringer Ingelheim Investigational Site	Leicester
United Kingdom	205.342.44005 Boehringer Ingelheim Investigational Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Russian Federation,  Slovakia,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial	Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit	baseline and after 16 weeks of treatment	No
Secondary	Mean Weekly Morning Peak Expiratory Flow at Week 4	Mean weekly morning peak expiratory flow at week 4, pre-dose	After 4 weeks of treatment	No
Secondary	Mean Weekly Morning Peak Expiratory Flow at Week 8	Mean weekly morning peak expiratory flow at week 8, pre-dose	After 8 weeks of treatment	No
Secondary	Mean Weekly Morning Peak Expiratory Flow at Week 12	Mean weekly morning peak expiratory flow at week 12, pre-dose	After 12 weeks of treatment	No
Secondary	Mean Weekly Morning Peak Expiratory Flow at Week 16	Mean weekly morning peak expiratory flow at week 16, pre-dose	After 16 weeks of treatment	No
Secondary	Mean Weekly Evening Peak Expiratory Flow at Week 4	Mean weekly evening peak expiratory flow at week 4, pre-dose	After 4 weeks of treatment	No
Secondary	Mean Weekly Evening Peak Expiratory Flow at Week 8	Mean weekly evening peak expiratory flow at week 8, pre-dose	After 8 weeks of treatment	No
Secondary	Mean Weekly Evening Peak Expiratory Flow at Week 12	Mean weekly evening peak expiratory flow at week 12, pre-dose	After 12 weeks of treatment	No
Secondary	Mean Weekly Evening Peak Expiratory Flow at Week 16	Mean weekly evening peak expiratory flow at week 16, pre-dose	After 16 weeks of treatment	No
Secondary	Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4	Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose	After 4 weeks of treatment	No
Secondary	Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8	Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose	After 8 weeks of treatment	No
Secondary	Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12	Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose	After 12 weeks of treatment	No
Secondary	Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16	Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose	After 16 weeks of treatment	No
Secondary	Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4	Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose	After 4 weeks of treatment	No
Secondary	Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8	Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose	After 8 weeks of treatment	No
Secondary	Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12	Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose	After 12 weeks of treatment	No
Secondary	Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16	Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose	After 16 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4	Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value	After 4 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8	Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value	After 8 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12	Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value	After 12 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16	Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value	After 16 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 4 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 8 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 12 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 16 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 4 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 8 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 12 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16	Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value	After 16 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4	Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value	After 4 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8	Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value	After 8 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12	Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value	After 12 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16	Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value	After 16 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4	Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value	After 4 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8	Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value	After 8 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12	Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value	After 12 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16	Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value	After 16 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4	Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value	After 4 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8	Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value	After 8 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12	Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value	After 12 weeks of treatment	No
Secondary	Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16	Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value	After 16 weeks of treatment	No
Secondary	Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3	Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment	After 6 weeks of treatment	No
Secondary	Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4	Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5	Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment	After 16 weeks of treatment	No
Secondary	Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3	Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment	After 6 weeks of treatment	No
Secondary	Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4	Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment	After 12 weeks of treatment	No
Secondary	Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5	Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment	After 16 weeks of treatment	No
Secondary	Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3	Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value	After 6 weeks of treatment	No
Secondary	Mini-AQLQ Overall Score at Visit 4	Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value	After 12 weeks of treatment	No
Secondary	Mini-AQLQ Overall Score at Visit 5	Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value	After 16 weeks of treatment	No
Secondary	Systolic Blood Pressure in Conjunction With Spirometry at Visit 3	Systolic blood pressure collected in conjunction with spirometry at 6 weeks	After 6 weeks of treatment	No
Secondary	Systolic Blood Pressure in Conjunction With Spirometry at Visit 4	Systolic blood pressure collected in conjunction with spirometry at 12 weeks	After 12 weeks of treatment	No
Secondary	Systolic Blood Pressure in Conjunction With Spirometry at Visit 5	Systolic blood pressure collected in conjunction with spirometry at 16 weeks	After 16 weeks of treatment	No
Secondary	Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3	Diastolic blood pressure collected in conjunction with spirometry at 6 weeks	After 6 weeks of treatment	No
Secondary	Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4	Diastolic blood pressure collected in conjunction with spirometry at 12 weeks	After 12 weeks of treatment	No
Secondary	Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5	Diastolic blood pressure collected in conjunction with spirometry at 16 weeks	After 16 weeks of treatment	No
Secondary	Pulse Rate in Conjunction With Spirometry at Visit 3	Pulse rate collected in conjunction with spirometry at 6 weeks	After 6 weeks of treatment	No
Secondary	Pulse Rate in Conjunction With Spirometry at Visit 4	Pulse rate collected in conjunction with spirometry at 12 weeks	After 12 weeks of treatment	No
Secondary	Pulse Rate in Conjunction With Spirometry at Visit 5	Pulse rate collected in conjunction with spirometry at 16 weeks	After 16 weeks of treatment	No
Secondary	Mean PEF Variability at Week 4	PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%	After 4 weeks of treatment	No
Secondary	Mean PEF Variability at Week 8	PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%	After 8 weeks of treatment	No
Secondary	Mean PEF Variability at Week 12	PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%	After 12 weeks of treatment	No
Secondary	Mean PEF Variability at Week 16	PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%	After 16 weeks of treatment	No

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