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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Phase III, 26-week 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: NCT00792805
• Other study ID #: CQAB149B2333
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2008
• Last updated: July 22, 2011
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

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
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
• Indacaterol 300 µg
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
• Placebo to indacaterol
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide
Australia	Novartis Investigative Site	Clayton
Australia	Novartis Investigative Site	Daw Park
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha
China	Novartis Investigative Site	Chongqing
China	Novartis Investigator Site	Fuzhou
China	Novartis Investigative Site	Guang Zhou
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
India	Novartis Investigative Site	Bangalore
India	Novartis Investigative Site	Trivandrum

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  China,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) at 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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.	Week 12 + 1 day, Day 85	No