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NVA237 BID Versus Placebo Twelve-week Efficacy Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

NVA237 BID Versus Placebo Twelve-week Efficacy Study

A 12-week Multi-center, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of NVA237 in Stable COPD Patients

NCT01715298•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•3\. Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion Criteria

•1. Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
•2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
•3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
•4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
•5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
•6. Patients with a body mass index (BMI) of more than 40 kg/m2.
•7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
•8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.

Locations (59)

Novartis Investigative Site

*See Various Dept.'s*, Arizona, United States

Novartis Investigative Site

Chandler, Arizona, United States

Novartis Investigative Site

Fresno, California, United States

Novartis Investigative Site

Fullerton, California, United States

Novartis Investigative Site

Yorba Linda, California, United States

Novartis Investigative Site

Yorba Linda, California, United States

Novartis Investigative Site

Boulder, Colorado, United States

Novartis Investigative Site

Wheat Ridge, Colorado, United States

Novartis Investigative Site

Lynn Haven, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

March 11, 2015

Enrollment

432

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

NVA237

DRUG

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: March 11, 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.

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NVA237 BID Versus Placebo Twelve-week Efficacy Study

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

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