Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00792805

Last Updated: 2011-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 563 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-02-28

Brief Summary

This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.

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 inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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

Intervention Type: DRUG

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

Indacaterol 300 μg

Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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

Intervention Type: DRUG

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

Placebo to indacaterol

Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. 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 to indacaterol

Intervention Type: DRUG

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

Interventions

Indacaterol 150 µg

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

Intervention Type: DRUG

Indacaterol 300 μg

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

Intervention Type: DRUG

Placebo to indacaterol

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults aged ≥ 40 years
• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

1. Smoking history of at least 10 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 received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
• 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 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 Investigative Site

Adelaide, , Australia

Novartis Investigative Site

Clayton, , Australia

Novartis Investigative Site

Daw Park, , Australia

Novartis Investigative Site

Beijing, , China

Novartis Investigative Site

Changsha, , China

Novartis Investigative Site

Chongqing, , China

Novartis Investigator Site

Fuzhou, , China

Novartis Investigative Site

Guangzhou, , China

Novartis Investigative Site

Shandong, , China

Novartis Investigative Site

Shanghai, , China

Novartis Investigative Site

Shenyang, , China

Novartis Investigative Site

Shijiazhuang, , China

Novartis Investigative Site

Xi'an, , China

Novartis Investigative Site

Bangalore, , India

Novartis Investigative Site

Trivandrum, , India

Countries

Australia; China; India

References

Yao W, Wang C, Zhong N, Han X, Wu C, Yan X, Chen P, Yang W, Henley M, Kramer B. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study. Respirology. 2014 Feb;19(2):231-238. doi: 10.1111/resp.12211. Epub 2014 Jan 3.

Reference Type: DERIVED

PMID: 24383720 (View on PubMed)

Other Identifiers

CQAB149B2333

Identifier Type: -

Identifier Source: org_study_id