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

NCT ID: NCT00876694

Last Updated: 2011-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-10-31

Brief Summary

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This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Indacaterol 300 µg

Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Group Type EXPERIMENTAL

Indacaterol 300 µg

Intervention Type DRUG

Indacaterol 300 µg once daily (od) via SDDPI

Salmeterol 50 µg

Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Group Type ACTIVE_COMPARATOR

Salmeterol 50 µg

Intervention Type DRUG

Salmeterol 50 µg twice daily (bid) via Diskus®

Interventions

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Indacaterol 300 µg

Indacaterol 300 µg once daily (od) via SDDPI

Intervention Type DRUG

Salmeterol 50 µg

Salmeterol 50 µg twice daily (bid) via Diskus®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:

* Smoking history of at least 20 pack-years
* Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria

1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
3. Patients with concomitant pulmonary disease
4. Patients with a history of asthma
5. Patients with diabetes Type I or uncontrolled diabetes Type II
6. Any patient with lung cancer or a history of lung cancer
7. Patients with a history of certain cardiovascular comorbid conditions
8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Asahikawa, , Japan

Site Status

Novartis Investigator Site

Bunkyō City, , Japan

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Gifu, , Japan

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Hamamatsu, , Japan

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Himeji, , Japan

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Hiroshima, , Japan

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Iwata, , Japan

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Kanazawa, , Japan

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Kasaoka, , Japan

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Kawasaki, , Japan

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Kishiwada, , Japan

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Kitakyushu, , Japan

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Kochi, , Japan

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Koga, , Japan

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Kurume, , Japan

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Kyoto, , Japan

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Maebashi, , Japan

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Matsusaka, , Japan

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Morioka, , Japan

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Nagaoka, , Japan

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Nagoya, , Japan

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Naka-gun, , Japan

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Noda, , Japan

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Obihiro, , Japan

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Sakai, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Setagaya-ku, , Japan

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Sumida-ku, , Japan

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Tenri, , Japan

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Tokyo, , Japan

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Ube, , Japan

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Wakayama, , Japan

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Yabu, , Japan

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Yanagawa, , Japan

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Yokkaichi, , Japan

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Novartis Investigator Site

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CQAB149B1303

Identifier Type: -

Identifier Source: org_study_id