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

NCT ID: NCT00794157

Last Updated: 2011-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-10-31

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Indacaterol 150 µg

Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol 150 μg capsules

Intervention Type: DRUG

Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Indacaterol 300 µg

Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol 300 μg capsules

Intervention Type: DRUG

Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Placebo

Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type: PLACEBO_COMPARATOR

Placebo capsules

Intervention Type: DRUG

Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Interventions

Indacaterol 150 μg capsules

Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Intervention Type: DRUG

Indacaterol 300 μg capsules

Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Intervention Type: DRUG

Placebo capsules

Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigator Site

Hong Kong, , Hong Kong

Novartis Investigator Site

New Territories, , Hong Kong

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, , India

Novartis Investigative Site

Asahikawa, , Japan

Novartis Investigative Site

Bunkyō City, , 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, , Japan

Novartis Investigative Site

Morioka, , Japan

Novartis Investigator Site

Nagaoka, , 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, , Japan

Novartis Investigator Site

Singapore, , Singapore

Novartis Investigator Site

Daegu, , South Korea

Novartis Investigator Site

Junggu, , South Korea

Novartis Investigative Site

Kangwon-Do, , South Korea

Novartis Investigator Site

Pusan, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigator Site

Seoul, , South Korea

Novartis Investigator Site

Chiayi City, , Taiwan

Novartis Investigator Site

Kaohsiung City, , Taiwan

Novartis Investigative Site

Keelung, , Taiwan

Novartis Investigative Site

Linkou District, , 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, , Taiwan

Novartis Investigator Site

Xindian District, , Taiwan

Countries

Hong Kong; India; Japan; Singapore; South Korea; Taiwan

References

To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5.

Reference Type: DERIVED

PMID: 23040786 (View on PubMed)

Other Identifiers

CQAB149B1302

Identifier Type: -

Identifier Source: org_study_id