Loading clinical trials...

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT02418468•Novartis Pharmaceuticals

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

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Novartis Investigative Site

Hong Kong, Hong Kong

Key Dates

Start Date

April 28, 2015

Primary Completion Date

April 19, 2016

Completion Date

April 19, 2016

Last Updated

July 11, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease