Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418468
• Other study ID #: CQAB149BHK02
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2015
• Last updated: August 11, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B.

This is a 2-arm parallel group study that will recruit COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients will be randomized in the ratio 1:1 to receive prn salbutamol plus:

1. Indacaterol 150ug or

2. Placebo for indacaterol all od for 26 weeks. The primary objective (trough FEV1) will be assessed after 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion criteria

1. Male or female adults aged =40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.

2. Patients diagnosed with COPD at 40 years of age or older.

3. Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)

4. Patients with stable COPD in Patient Group B according to GOLD 2014.

Exclusion criteria

1. Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days /until the expected PD effect has returned to baseline], whichever is longer.

2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.

3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

4. Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.

5. Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.

6. Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.

7. Patients with a history of asthma.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
Patients are randomized to receive indacaterol plus prn salbutamol
• Placebo
Patients are randomized to receive placebo for indacaterol plus prn salbutamol

Locations

Country	Name	City	State
Hong Kong	Novartis Investigative Site	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough forced expiratory volume in 1 second (FEV1)	To compare the effects of indacaterol 150ug once dialy (od) plus as required (prn) salbutamol with prn salbutamol plus placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.	at week 12	No
Secondary	Adverse events	To evaluate the effects of indacaterol 150ug od plus prn salbutamol and prn salbutamol plus placebo on safety in terms of adverse events (AEs) and serious adverse events over 26 weeks.	Over 26 weeks	Yes