Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794157
• Other study ID #: CQAB149B1302
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2008
• Last updated: July 22, 2011
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareIndia: Ministry of HealthTaiwan: Department of HealthHong Kong: Department of HealthSingapore: Health Sciences AuthorityKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:

1. Smoking history of at least 20 pack-years.

2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and = 30% of the predicted normal value.

3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%.

Exclusion Criteria:

• Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.

• Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia.

• Patients who have had a respiratory tract infection within 6 weeks prior to screening.

• Patients with concomitant pulmonary disease.

• Patients with a history of asthma.

• Patients with diabetes Type I or uncontrolled diabetes Type II.

• Any patient with lung cancer or a history of lung cancer.

• Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.

• Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.

• Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.

• Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, 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 capsules
Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
• Indacaterol 300 µg capsules
Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
• Placebo capsules
Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Locations

Country	Name	City	State
Hong Kong	Novartis Investigator Site	Hong Kong
Hong Kong	Novartis Investigator Site	New Territories
India	Novartis Investigative Site	Ahmedabad
India	Novartis Investigator Site	Bangalore
India	Novartis Investigative Site	Coimbatore
India	Novartis Investigator Site	Coimbatore
India	Novartis Investigator Site	India
India	Novartis Investigative Site	Mumbai
India	Novartis Investigative Center	Panjim
Japan	Novartis Investigative Site	Asahikawa
Japan	Novartis Investigative Site	Bunkyo-ku
Japan	Novartis Investigator Site	Gifu
Japan	Novartis Investigator Site	Himeji
Japan	Novartis Investigator Site	Hiroshima
Japan	Novartis Investigator Site	Iwata
Japan	Novartis Investigator Site	Kanazawa
Japan	Novartis Investigative site	Kawasaki
Japan	Novartis Investigator Site	Kishiwada
Japan	Novartis Investigator Site	Kitakyushu
Japan	Novartis Investigator Site	Kochi
Japan	Novartis Investigator Site	Koga
Japan	Novartis Investigative Site	Kurume
Japan	Novartis Investigator Site	Kyoto
Japan	Novartis Investigative Site	Maebashi
Japan	Novartis Investigator Site	Matsusaka-City
Japan	Novartis Investigative Site	Morioka
Japan	Novartis Investigator Site	Nagaoka-City
Japan	Novartis Investigator Site	Nagoya
Japan	Novartis Investigative Site	Noda
Japan	Novartis Investigative Site	Obihiro
Japan	Novartis Investigator Site	Sakai
Japan	Novartis Investigative Site	Sapporo
Japan	Novartis Investigator Site	Sendai
Japan	Novartis Investigator Site	Seto
Japan	Novartis Investigator Site	Tenri
Japan	Novartis Investigative site	Tokyo
Japan	Novartis Investigator Site	Toyonaka
Japan	Novartis Investigator Site	Ube
Japan	Novartis Investigator Site	Wakayama
Japan	Novartis Investigator Site	Yabu
Japan	Novartis Investigator Site	Yanagawa
Japan	Novartis Investigator Site	Yokkaichi
Japan	Novartis Investigative Site	Yokohama
Korea, Republic of	Novartis Investigator Site	Daegu
Korea, Republic of	Novartis Investigator Site	Jung-gu
Korea, Republic of	Novartis Investigative Site	Kangwon-Do
Korea, Republic of	Novartis Investigator Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigator Site	Seoul
Singapore	Novartis Investigator Site	Singapore
Taiwan	Novartis Investigator Site	Chia-Yi
Taiwan	Novartis Investigator Site	Hsintien
Taiwan	Novartis Investigator Site	Kaohsiung
Taiwan	Novartis Investigative Site	Keelung
Taiwan	Novartis Investigative Site	LinKou
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigator Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigator Site	Taipei
Taiwan	Novartis Investigator Site	Taipei County

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Hong Kong,  India,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	End of treatment (Week 12 + 1 day, Day 85)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	After Week 2 (Day 15)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	After Week 4 (Day 29)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	After Week 8 (Day 57)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	Prior to last dose at Week 12 (Day 84)	No