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

NCT02418468 | Completed Phase 4 Results

• 1 other identifier: CQAB149BHK02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B. This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus:

1. 1.Indacaterol 150ug or
2. 2.Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, FEV1, indacaterol

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks

  To compare the effects of indacaterol 150ug once dialy (od) to 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

Study Arms (2)

Placebo

EXPERIMENTAL

Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)

Drug: Placebo

Indacaterol 150 mcg

EXPERIMENTAL

Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)

Drug: Indacaterol

Interventions

Indacaterol DRUG

Indacaterol 150µg capsules for inhalation daily

Indacaterol 150 mcg

Placebo DRUG

Matching placebo indacaterol capsules for inhalation daily

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Patients diagnosed with COPD at 40 years of age or older.
• 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)
• Patients with stable COPD in Patient Group B according to GOLD 2014.

You may not qualify if:

• 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.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• 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.
• 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.
• Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
• Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
• Patients with a history of asthma.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Hong Kong, Hong Kong

Location

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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: April 28, 2015
• Primary Completion: April 19, 2016
• Study Completion: April 19, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-04

Locations

HK (1)