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

NCT00794157 | Completed Phase 3 Results

• 1 other identifier: CQAB149B1302
• Study Type: interventional
• Target: 347
• Locations: 6 countries
• Sites: 60

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)

Keywords

COPD; chronic obstructive pulmonary disease; indacaterol; long acting β2-agonist

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2

  After Week 2 (Day 15)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4

  After Week 4 (Day 29)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8

  After Week 8 (Day 57)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)

  Prior to last dose at Week 12 (Day 84)

Study Arms (3)

Indacaterol 150 µg

EXPERIMENTAL

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.

Drug: Indacaterol 150 μg capsules

Indacaterol 300 µg

EXPERIMENTAL

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.

Drug: Indacaterol 300 μg capsules

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo capsules

Interventions

Indacaterol 150 μg capsules DRUG

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

Indacaterol 150 µg

Indacaterol 300 μg capsules DRUG

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

Indacaterol 300 µg

Placebo capsules DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:
• Smoking history of at least 20 pack-years.
• Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
• Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (60)

Novartis Investigator Site

Hong Kong, Hong Kong

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New Territories, Hong Kong

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Ahmedabad, India

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Bangalore, India

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Coimbatore, India

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Coimbatore, India

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India, India

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Mumbai, India

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Novartis Investigative Center

Panjim, India

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Asahikawa, Japan

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Bunkyō City, Japan

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Gifu, 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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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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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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Seto, Japan

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Tenri, Japan

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Tokyo, Japan

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Toyonaka, 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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Yokohama, Japan

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Singapore, Singapore

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Daegu, South Korea

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Junggu, South Korea

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Kangwon-Do, South Korea

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Pusan, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Chiayi City, Taiwan

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Kaohsiung City, Taiwan

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Keelung, Taiwan

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Linkou District, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei County, Taiwan

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Xindian District, Taiwan

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Related Publications (1)

• 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.

  PMID: 23040786 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 17, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-07

Locations

IN (7); JP (34); SG (1); KR (6); HK (2); TW (10)