MedDataX Logo

NVA237 BID Versus Placebo Twelve-week Efficacy Study

NCT ID: NCT01715298

Last Updated: 2015-03-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NVA237 Versus Placebo 12-week Efficacy Study

NCT01709864

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01154127

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

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

NCT01566604

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00856193

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE2

Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium

NCT00501852

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NVA237

NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks

Group Type EXPERIMENTAL

NVA237

Intervention Type DRUG

NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules

Placebo

Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NVA237

NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules

Intervention Type DRUG

Placebo

Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

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

Site Status

Novartis Investigative Site

Chandler, Arizona, United States

Site Status

Novartis Investigative Site

Fresno, California, United States

Site Status

Novartis Investigative Site

Fullerton, California, United States

Site Status

Novartis Investigative Site

Yorba Linda, California, United States

Site Status

Novartis Investigative Site

Yorba Linda, California, United States

Site Status

Novartis Investigative Site

Boulder, Colorado, United States

Site Status

Novartis Investigative Site

Wheat Ridge, Colorado, United States

Site Status

Novartis Investigative Site

Lynn Haven, Florida, United States

Site Status

Novartis Investigative Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Port Orange, Florida, United States

Site Status

Novartis Investigative Site

Winter Park, Florida, United States

Site Status

Novartis Investigative Site

Conyers, Georgia, United States

Site Status

Novartis Investigative Site

River Forest, Illinois, United States

Site Status

Novartis Investigative Site

Skokie, Illinois, United States

Site Status

Novartis Investigative Site

Evansville, Indiana, United States

Site Status

Novartis Investigative Site

Lexington, Kentucky, United States

Site Status

Novartis Investigative Site

Sunset, Louisiana, United States

Site Status

Novartis Investigative Site

Fall River, Massachusetts, United States

Site Status

Novartis Investigative Site

North Dartmouth, Massachusetts, United States

Site Status

Novartis Investigative Site

Minneapolis, Minnesota, United States

Site Status

Novartis Investigative Site

Plymouth, Minnesota, United States

Site Status

Novartis Investigative Site

Saint Charles, Missouri, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

Fremont, Nebraska, United States

Site Status

Novartis Investigative Site

Lincoln, Nebraska, United States

Site Status

Novartis Investigative Site

Omaha, Nebraska, United States

Site Status

Novartis Investigative Site

Cherry Hill, New Jersey, United States

Site Status

Novartis Investigative Site

Albuquerque, New Mexico, United States

Site Status

Novartis Investigative Site

Brooklyn, New York, United States

Site Status

Novartis Investigative Site

Brooklyn, New York, United States

Site Status

Novartis Investigative Site

Great Neck, New York, United States

Site Status

Novartis Investigative Site

Massapequa, New York, United States

Site Status

Novartis Investigative Site

New Windsor, New York, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Charlotte, North Carolina, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Columbus, Ohio, United States

Site Status

Novartis Investigative Site

Medford, Oregon, United States

Site Status

Novartis Investigative Site

Medford, Oregon, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Langhorne, Pennsylvania, United States

Site Status

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Novartis Investigative Site

Pottstown, Pennsylvania, United States

Site Status

Novartis Investigative Site

Tipton, Pennsylvania, United States

Site Status

Novartis Investigative Site

East Providence, Rhode Island, United States

Site Status

Novartis Investigative Site

Fort Mill, South Carolina, United States

Site Status

Novartis Investigative Site

Rock Hll, South Carolina, United States

Site Status

Novartis Investigative Site

Denton, Texas, United States

Site Status

Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Midvale, Utah, United States

Site Status

Novartis Investigative Site

South Burlington, Vermont, United States

Site Status

Novartis Investigative Site

Richmond, Virginia, United States

Site Status

Novartis Investigative Site

Richmond, Virginia, United States

Site Status

Novartis Investigative Site

Tacoma, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Kerwin E, Siler TM, Korenblat P, White A, Eckert JH, Henley M, Patalano F, D'Andrea P. Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study. Chronic Obstr Pulm Dis. 2016 Mar 28;3(2):549-559. doi: 10.15326/jcopdf.3.2.2015.0157.

Reference Type DERIVED
PMID: 28848879 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CNVA237A2318

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01119950 COMPLETED PHASE2
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
NCT06154837 RECRUITING PHASE1
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
NCT01005901 COMPLETED PHASE3
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01529632 COMPLETED PHASE3
Long Term Safety Study of NVA237 vs QAB149 in COPD Patients
NCT01697696 COMPLETED PHASE3
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
NCT01513460 COMPLETED PHASE3
Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS
NCT01757015 WITHDRAWN PHASE3
A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
NCT02371629 COMPLETED PHASE4
Simvastatin in Chronic Obstructive Pulmonary Disease (COPD)
NCT00680641 UNKNOWN PHASE4
Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00545311 COMPLETED PHASE1
A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation
NCT01712516 COMPLETED PHASE3
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
NCT00929110 COMPLETED PHASE3
Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT00510510 COMPLETED PHASE2
Study in Patients With COPD
NCT00215449 COMPLETED PHASE3
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01013142 COMPLETED PHASE1
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT02294734 COMPLETED PHASE2
Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01613326 COMPLETED PHASE3
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
NCT00215436 COMPLETED PHASE3
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of RV1729 for 28 Days in Patients With COPD
NCT02140346 COMPLETED PHASE1
Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators
NCT07133880 RECRUITING PHASE4
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
NCT02634983 COMPLETED PHASE4
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
NCT00285012 COMPLETED PHASE3
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
NCT04882124 COMPLETED PHASE2
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00144859 COMPLETED PHASE2
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD
NCT00280371 COMPLETED PHASE3