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Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease

NCT01513460•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline
•Current or ex-smokers who have a smoking history of at least 10 pack years
•Qualifying FEV1 at Visit 2 (day -7)

Exclusion Criteria

•Patients with a history of asthma or a history of high blood eosinophil count (\>600/mm³)
•Patients with concomitant pulmonary disease
•Patients with lung lobectomy or lung volume reduction or lung transplantation
•Patients with α-1 antitrypsin deficiency
•Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period

Locations (71)

Novartis Investigative Site

Baulkham Hills, New South Wales, Australia

Novartis Investigative Site

Brookvale, New South Wales, Australia

Novartis Investigative Site

Castle Hill, New South Wales, Australia

Novartis Investigative Site

Dapto, New South Wales, Australia

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Ermington, New South Wales, Australia

Novartis Investigative Site

Gosford, New South Wales, Australia

Novartis Investigative Site

Hinchinbrook, New South Wales, Australia

Novartis Investigative Site

Kingswood, New South Wales, Australia

Novartis Investigative Site

Sydney, New South Wales, Australia

Key Dates

Start Date

April 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

January 5, 2015

Enrollment

773

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

NVA237 50µg once daily

DRUG

Tiotropium 18µg once daily

DRUG

Flu/Sal

DRUG

NVA237 placebo + Tiotropium placebo.

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

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

NCT05878769

Chronic Obstructive Pulmonary Disease

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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: January 5, 2015Data 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

Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Inclusion Criteria

Exclusion Criteria

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

Probiotics in Pulmonaty Rehabilitation for COPD

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