Tiotropium In Exercise

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525512
• Other study ID #: 205.368
• Secondary ID: 2006-004610-41
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2007
• Last updated: November 27, 2013
• Start date: August 2007

Study information

• Verified date: September 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: A.N.M.A.T. (National administration of Medecines, Foods and Medical Technology)Brazil: ANVISACanada: Therapeutic Products DirectorateGermany: Federal Institute for Drug and Medicine ProductsItaly: Comitato Etico dell'Azienda Osp. Universitaria PisanaPortugal: National Pharmacy and Medicines InstituteRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSpain: Agencia Espanola de Medicamentos y Productos SantariosTaiwan: Department of Health, Executive Yuan, TaiwanUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion criteria

1. All patients must sign an informed consent

2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)

3. Age >= 40 years

4. Medical Research Council Dyspnoea score >= 2

5. Current or ex-smoker with a >= 10 pack-year smoking history

6. Ability to exercise on treadmill

Exclusion criteria

1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment

2. Clinical history of asthma

3. Use of supplemental oxygen therapy

4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)

5. Recent history (<= 12 months) of myocardial infarction

6. Unstable or life-threatening cardiac arrhythmia

7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years

8. Pregnant or nursing women

9. Known hypersensitivity to anticholinergic drugs or any component of the study medications

10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1

11. Estimated life expectancy < 2 years

12. Symptomatic prostatic hyperplasia or bladder neck obstruction

13. Known narrow-angle glaucoma

14. Any condition that is contraindicated for exercise

15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing

16. Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Exercise
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
• Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

Locations

Country	Name	City	State
Argentina	205.368.54001 Boehringer Ingelheim Investigational Site	Rosario
Argentina	205.368.54002 Boehringer Ingelheim Investigational Site	Vicente López
Brazil	205.368.55003 Boehringer Ingelheim Investigational Site	Goiânia
Brazil	205.368.55004 Boehringer Ingelheim Investigational Site	Porto Alegre - RS
Brazil	205.368.55002 Boehringer Ingelheim Investigational Site	Sao Paulo
Canada	205.368.07004 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	205.368.07005 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	205.368.07008 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	205.368.07006 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	205.368.07001 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
Canada	205.368.07003 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
Germany	205.368.49005 Boehringer Ingelheim Investigational Site	Berlin
Germany	205.368.49004 Boehringer Ingelheim Investigational Site	Freiburg/Breisgau
Germany	205.368.49003 Boehringer Ingelheim Investigational Site	Köln
Germany	205.368.49006 Boehringer Ingelheim Investigational Site	Münster
Germany	205.368.49002 Boehringer Ingelheim Investigational Site	Schmallenberg
Germany	205.368.49001 Boehringer Ingelheim Investigational Site	Tübingen
Italy	205.368.39006 Boehringer Ingelheim Investigational Site	Ferrara
Italy	205.368.39004 Boehringer Ingelheim Investigational Site	Milano
Italy	205.368.39002 Boehringer Ingelheim Investigational Site	Parma
Italy	205.368.39001 Boehringer Ingelheim Investigational Site	Pisa
Portugal	205.368.35103 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	205.368.35102 Boehringer Ingelheim Investigational Site	Matosinhos
Russian Federation	205.368.70001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.368.70004 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.368.70005 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.368.70006 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	205.368.70007 Boehringer Ingelheim Investigational Site	St. Petersburg
Spain	205.368.34005 Hospital Germans Trias i Pujol	Badalona (Barcelona)
Spain	205.368.34002 Hospital de Cruces	Barakaldo (Bilbao)
Spain	205.368.34001 Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	205.368.34003 Hospital Gregorio Maranon	Madrid
Spain	205.368.34004 Hospital Universitario Vírgen del Rocío	Sevilla
Spain	205.368.34006 Boehringer Ingelheim Investigational Site	Sevilla
Taiwan	205.368.88604 Boehringer Ingelheim Investigational Site	Keelung
Taiwan	205.368.88602 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	205.368.88603 Boehringer Ingelheim Investigational Site	Taipei City
Taiwan	205.368.88601 Chang Gung Memorial Hosp-Linkou	Taoyuan
Ukraine	205.368.38003 Boehringer Ingelheim Investigational Site	Dnyepropyetrovsk
Ukraine	205.368.38001 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	205.368.38002 Boehringer Ingelheim Investigational Site	Kiev
United States	205.368.01014 Boehringer Ingelheim Investigational Site	Albany	New York
United States	205.368.01016 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	205.368.01004 Boehringer Ingelheim Investigational Site	Bay Pines	Florida
United States	205.368.01029 Boehringer Ingelheim Investigational Site	Biddeford	Maine
United States	205.368.01002 Boehringer Ingelheim Investigational Site	Boston	Massachusetts
United States	205.368.01018 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	205.368.01015 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	205.368.01008 Boehringer Ingelheim Investigational Site	Fort Collins	Colorado
United States	205.368.01027 Boehringer Ingelheim Investigational Site	Gaffney	South Carolina
United States	205.368.01019 Boehringer Ingelheim Investigational Site	Greenville	South Carolina
United States	205.368.01017 Boehringer Ingelheim Investigational Site	Hartford	Connecticut
United States	205.368.01025 Boehringer Ingelheim Investigational Site	Hazard	Kentucky
United States	205.368.01023 Boehringer Ingelheim Investigational Site	Jasper	Alabama
United States	205.368.01021 Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	205.368.01003 Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	205.368.01013 Boehringer Ingelheim Investigational Site	North Miami Beach	Florida
United States	205.368.01022 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	205.368.01020 Boehringer Ingelheim Investigational Site	Spartanburg	South Carolina
United States	205.368.01030 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	205.368.01024 Boehringer Ingelheim Investigational Site	Union	South Carolina
United States	205.368.01028 Boehringer Ingelheim Investigational Site	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Germany,  Italy,  Portugal,  Russian Federation,  Spain,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 96 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 8 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 16 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 32 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 48 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 64 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 80 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 8 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 16 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 32 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 48 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 64 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 80 weeks	No
Secondary	Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 96 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 8 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 16 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 32 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 48 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 64 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 80 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 96 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 8 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 16 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 32 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 48 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 64 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 80 weeks	No
Secondary	Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 96 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 8 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 16 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 32 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 48 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 64 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 80 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 96 weeks	No
Secondary	Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase	Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)	baseline, 96 weeks	No
Secondary	Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase	Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)	baseline, 96 weeks	No
Secondary	Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase	Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)	baseline, 96 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 8 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 16 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 32 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 48 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 64 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 80 weeks	No
Secondary	Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 96 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 8 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 16 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 32 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 48 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 64 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 80 weeks	No
Secondary	Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase	The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)	baseline, 96 weeks	No
Secondary	Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 96 weeks	No
Secondary	Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 96 weeks	No
Secondary	Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 96 weeks	No
Secondary	Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 96 weeks	No
Secondary	Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase	COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.	baseline, 96 weeks	No
Secondary	90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase	Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.	baseline, 100 weeks	No
Secondary	Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase	FEV1 is the maximal amount of air you can forcefully exhale in one second.	baseline, 100 weeks	No
Secondary	Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase	FVC is the volume of air that can be forcibly blown out after full inspiration.	baseline, 100 weeks	No
Secondary	Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 100 weeks	No
Secondary	Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 100 weeks	No
Secondary	Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 100 weeks	No
Secondary	Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase	Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.	baseline, 100 weeks	No
Secondary	Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status	Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.	From first drug administration until 30 days after last drug administration	No

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