Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567996
• Other study ID #: CQAB149B2336
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2007
• Last updated: July 22, 2011
• Start date: November 2007

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIceland: Icelandic Medicines Control AgencyIndia: Ministry of HealthItaly: Ministry of HealthNorway: Norwegian Medicines AgencyPeru: Ministry of HealthRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlTaiwan: Department of HealthFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

• Smoking history of at least 20 pack years

• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value

• Post-bronchodilator FEV1/FVC < 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

• Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception

• Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in

• Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)

• Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period

• Concomitant pulmonary disease

• Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma

• History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females

• Patients who have a clinically significant condition or a clinically relevant laboratory abnormality

• History of reactions to sympathomimetic amines or inhaled medication

• Inability to use the dry powder devices or perform spirometry

• Irregular day/night, wake/sleep cycles, e.g. shift workers

• Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period

• Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 150 µg
Indacaterol 150 µg once daily (o.d) inhaled
• Salmeterol 50 µg
Salmeterol 50 µg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
• Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
• Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Edmonton
Canada	Novartis Investigator Site	Edmonton
Canada	Novartis Investigator Site	London
Canada	Novartis Investigator Site	Mirabel
Canada	Novartis Investigator Site	Montreal
Canada	Novartis Investigator Site	Toronto
Colombia	Novartis Investigator site	Barranquilla
Colombia	Novartis Investigator Site	Bogota D.C.
Colombia	Novartis Investigator Site	Medellin
Czech Republic	Novartis Investigator Site	Cvikov
Czech Republic	Novartis Investigator Site	Lovosice
Czech Republic	novartis Investigator site	Novy Jocin
Czech Republic	Novartis Investigator Site	Pardubice
Czech Republic	Novartis Investigator Site	Praha
Czech Republic	Novartis Investigative Site	Zatec
Denmark	Novartis Investigator Site	Aalborg
Denmark	Novartis Investigator Site	Arhus
Denmark	Novartis Investigative Site	Copenhagen
Denmark	Novartis Investigator Site	Copenhagen
Denmark	Novartis Investigator Site	Frederikssund
Denmark	Novartis investigator site	Hellerup
Denmark	Novartis Investigator site	Hvidovre
Denmark	Novartis investigator site	Odense
Denmark	Novartis Investigator Site	Roslev
Denmark	Novartis Investigative Site	Silkeborg
Denmark	Novartis Investgative Site	Soborg
Denmark	Novartis Investigator Site	Vaerloese
Finland	Novartis Investigator Site	Hus
Finland	Novartis Investigator Site	Jyvaskyla
Finland	Novartis Investigator Site	Lahti
Finland	Novartis Investigator Site	Oulu
Finland	Novartis Investigator Site	Tampere
Finland	Novartis Investigator Site	Turku
France	Novartis Investigative Site	Ambroise
France	Novartis Investigative Site	Beuvry
France	Novartis Investgative Site	Ferolles-Attilly
France	Novartis Investigator Site	Nice
Germany	Novartis Investigator Site	Bad Segeberg
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigator Site	Bielefeld
Germany	Novartis Investigator Site	Bochum
Germany	Novartis Investigator Site	Bonn
Germany	Novartis Investigator Site	Bruehl
Germany	Novartis Investigator Site	Cottbus
Germany	Novartis Investigator Site	Dortmund
Germany	Novartis Investigator Site	Dueren
Germany	Novartis Investigator Site	Eggenfelden
Germany	Novartis investigator site	Eschwege
Germany	Novartis Investigator Site	Forchheim
Germany	Novartis Investigator Site	Freudenberg
Germany	Novartis Investigator Site	Furth
Germany	Novartis Investigator Site	Gelsenkirchen
Germany	Novartis Investigator Site	Gummersbach
Germany	Novartis Investigator Site	Hagen
Germany	Novartis Investigator Site	Hannover
Germany	Novartis Investigator Site	Kassel
Germany	Novartis Investigator Site	Kempten
Germany	Novartis Investigator Site	Koeln
Germany	Novartis Investigator Site	Landsberg am Lech
Germany	Novartis Investigator Site	Langenfeld
Germany	Novartis Investigator Site	Leipzig
Germany	Novartis Investigator Site	Mainz
Germany	Novartis Investigator Site	Muenchen
Germany	Novartis Investigator Site	Munich
Germany	Novartis Investigator Site	Neuss
Germany	Novartis Investigator Site	Nuremburg
Germany	Novartis Investigator Site	Oschersleben
Germany	Novartis Investigator Site	Ruhmannsfelden
Germany	Novartis Investigator site	Sinsheim
Germany	Novartis Investigator Site	Solingen
Germany	Novartis Investigator Site	Steinfort-borghorst
Germany	Novartis Investigator Site	Vilshofen
Germany	Novartis Investigator Site	Wallerfing
Germany	Novartis Investigator Site	Witten
Hungary	Novartis Investigator Site	Budapest
Hungary	Novartis investigator site	Debrechen
Hungary	Novartis Investigator Site	Deszk
Hungary	Novartis Investigator Site	Mosonmagyarovar
Hungary	Novartis Investigator Site	Szekesfehervar
Iceland	Novartis investigator site	Reykhavik
India	Novartis Investigator Site	Chennai
India	Novartis Investigator Site	Coimbatore
India	Novartis Investigator Site	Goa
India	Novartis Investigator Site	Hyderabad
India	Novartis Investigator Site	Jaipur
India	Novartis Investigator Site	Kerala
India	Novartis Investigator Site	Mangalore
India	Novartis Investigator Site	Mumbai
India	Novartis Investigator Site	Vellore
Italy	Novartis Investigator Site	Ancona
Italy	Novartis Investigator Site	Arenzano
Italy	Novartis Investigative Site	Ascoli Piceno
Italy	Novartis Investigator Site	Brescia
Italy	Novartis Investigator Site	Cagliari
Italy	Novartis investigator site	Chieti
Italy	Novartis Investigator Site	Ferrara
Italy	Novartis Investigator Site	Milan
Italy	Novartis Investigator Site	Milano
Italy	Novartis Investigator Site	Orbassano
Italy	Novartis Investigator Site	Palermo
Italy	Novartis Investigator Site	Reggio Emilia
Italy	Novartis Investigator Site	Rome
Italy	Novartis Investigator Site	Sesto
Italy	Novartis Investigator Site	Siena
Italy	Novartis Investigator Site	Terni
Peru	Novartis Investigator Site	Callao
Peru	Novartis Investigator Site	Miraflores
Peru	Novartis Investigator Site	San Borja
Peru	Novartis Investigator Site	San Isidro
Peru	Novartis Investigator Site	San Martin de Porres
Peru	Novartis Investigator Site	Surco
Russian Federation	Novartis Investigator Site	Ekaterinburg
Russian Federation	Novartis Investigator Site	Kazan
Russian Federation	Novartis Investigator Site	Moscow
Russian Federation	Novartis Investigator Site	Saint Petersburg
Russian Federation	Novartis Investigator Site	Samara
Russian Federation	Novartis Investigator Site	St Petersburg
Russian Federation	Novartis Investigator Site	Yaroslavl
Russian Federation	Novartis Investigator Site	Yekaterinburg
Slovakia	Novartis Investigator Site	Bardejov
Slovakia	Novartis Investigator Site	Bratislava
Slovakia	Novartis Investigator Site	Kosice
Slovakia	Novartis Investigator Site	Kovice
Slovakia	Novartis Investigator Site	Spisska
Taiwan	Novartis Investigator Site	Changhua
Taiwan	Novartis Investigator Site	Kaohsiung
Taiwan	Novartis Investigator Site	Kaohusing
Taiwan	Novartis Investigator Site	Lin-ko
Taiwan	Novartis Investigator Site	Taichung
Taiwan	Novartis Investigator Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Canada,  Colombia,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Iceland,  India,  Italy,  Peru,  Russian Federation,  Slovakia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment	Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.	Week 12	No
Secondary	St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment	SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.	Week 12	No
Secondary	Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment	Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.	Up to 26 weeks	No