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NVA237 Versus Placebo 12-week Efficacy Study

NCT ID: NCT01709864

Last Updated: 2015-03-04

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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 (glycopyrronium 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

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NVA237

NVA237 (glycopyrronium 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

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Inclusion Criteria

1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011).
2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and \<80 % of the predicted normal, and FEV1/ Forced Vital Capacity (FVC) \< 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.
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

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Homewood, Alabama, United States

Site Status

Novartis Investigative Site

Jasper, Alabama, United States

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Novartis Investigative Site

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

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Novartis Investigative Site

Tucson, Arizona, United States

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Novartis Investigative Site

Fountain Valley, California, United States

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Novartis Investigative Site

Fullerton, California, United States

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Novartis Investigative Site

Los Angeles, California, United States

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Novartis Investigative Site

Los Angeles, California, United States

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Novartis Investigative Site

Riverside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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DeFuniak Springs, Florida, United States

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Edgewater, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Pompano Beach, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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Summerfield, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Shelby, North Carolina, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Easley, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Novartis Investigative Site

Ninety Six, South Carolina, United States

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Novartis Investigative Site

Rock Hll, South Carolina, United States

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Novartis Investigative Site

Seneca, South Carolina, United States

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Simpsonville, South Carolina, United States

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Novartis Investigative Site

Spartanburg, South Carolina, United States

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Novartis Investigative Site

Union, South Carolina, United States

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Novartis Investigative Site

Amarillo, Texas, United States

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Novartis Investigative Site

Arlington, Texas, United States

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Novartis Investigative Site

Arlington, Texas, United States

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Novartis Investigative Site

Beaumont, Texas, United States

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Novartis Investigative Site

Dallas, Texas, United States

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Novartis Investigative Site

Huntsville, Texas, United States

Site Status

Novartis Investigative Site

Waco, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CNVA237A2317

Identifier Type: -

Identifier Source: org_study_id

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