NVA237 BID Versus Placebo Twelve-week Efficacy Study

NCT01715298 | Completed Phase 3 Results

• 1 other identifier: CNVA237A2318
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 59

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Anticholinergic; Antimuscarinic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; COPD; LAMA; Lung Disease; Lung Diseases, Obstructive; Lung Function; Muscarinic receptor antagonist; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing

  The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur

  Week 12

Secondary Outcomes (15)

• Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing

  Day 1

• Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing

  Day 1 and Week 12

• Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints

  Day 1 and week 12

• Mean Trough Forced Expiratory Volume in One Second

  Day 1 and week 12

• Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire

  Week 12

Study Arms (2)

NVA237

EXPERIMENTAL

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

Drug: NVA237

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

NVA237 DRUG

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

NVA237

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
• Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
• 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.
• Patients with a body mass index (BMI) of more than 40 kg/m2.
• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (59)

Novartis Investigative Site

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

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Novartis Investigative Site

Chandler, Arizona, 85224, United States

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Novartis Investigative Site

Fresno, California, 93726, United States

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Novartis Investigative Site

Fullerton, California, 92835, United States

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Novartis Investigative Site

Yorba Linda, California, 92886-7921, United States

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Novartis Investigative Site

Yorba Linda, California, 92886, United States

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Novartis Investigative Site

Boulder, Colorado, 80304, United States

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Novartis Investigative Site

Wheat Ridge, Colorado, 80033, United States

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Novartis Investigative Site

Lynn Haven, Florida, 32444, United States

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Novartis Investigative Site

Miami, Florida, 33173, United States

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Novartis Investigative Site

Port Orange, Florida, 32127, United States

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Novartis Investigative Site

Winter Park, Florida, 32789, United States

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Novartis Investigative Site

Conyers, Georgia, 30094, United States

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Novartis Investigative Site

River Forest, Illinois, 60305, United States

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Novartis Investigative Site

Skokie, Illinois, 60076, United States

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Novartis Investigative Site

Evansville, Indiana, 47714, United States

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Novartis Investigative Site

Lexington, Kentucky, 40509, United States

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Novartis Investigative Site

Sunset, Louisiana, 70584, United States

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Novartis Investigative Site

Fall River, Massachusetts, 02720, United States

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Novartis Investigative Site

North Dartmouth, Massachusetts, 02747, United States

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Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

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Novartis Investigative Site

Plymouth, Minnesota, 55441, United States

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Novartis Investigative Site

Saint Charles, Missouri, 63301, United States

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Novartis Investigative Site

St Louis, Missouri, 63128, United States

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Novartis Investigative Site

St Louis, Missouri, 63141, United States

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Novartis Investigative Site

Fremont, Nebraska, 68025, United States

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Novartis Investigative Site

Lincoln, Nebraska, 68510, United States

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Novartis Investigative Site

Omaha, Nebraska, 68114, United States

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Novartis Investigative Site

Cherry Hill, New Jersey, 08003, United States

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Novartis Investigative Site

Albuquerque, New Mexico, 87108, United States

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Novartis Investigative Site

Brooklyn, New York, 11229, United States

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Novartis Investigative Site

Brooklyn, New York, 11234, United States

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Novartis Investigative Site

Great Neck, New York, 11021, United States

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Novartis Investigative Site

Massapequa, New York, 11758, United States

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Novartis Investigative Site

New Windsor, New York, 12553, United States

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Novartis Investigative Site

New York, New York, 10003, United States

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Novartis Investigative Site

New York, New York, 10028, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45231, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45242, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45245, United States

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Novartis Investigative Site

Columbus, Ohio, 43213, United States

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Novartis Investigative Site

Medford, Oregon, 97504-8741, United States

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Novartis Investigative Site

Medford, Oregon, 97504, United States

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Novartis Investigative Site

Portland, Oregon, 97213, United States

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Novartis Investigative Site

Langhorne, Pennsylvania, 19047, United States

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Novartis Investigative Site

Pittsburgh, Pennsylvania, 15243, United States

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Novartis Investigative Site

Pottstown, Pennsylvania, 19464, United States

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Novartis Investigative Site

Tipton, Pennsylvania, 16684, United States

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Novartis Investigative Site

East Providence, Rhode Island, 02914, United States

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Novartis Investigative Site

Fort Mill, South Carolina, 29707, United States

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Novartis Investigative Site

Rock Hll, South Carolina, 29732, United States

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Novartis Investigative Site

Denton, Texas, 76210, United States

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Novartis Investigative Site

San Antonio, Texas, 78229, United States

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Novartis Investigative Site

Midvale, Utah, 84047, United States

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Novartis Investigative Site

South Burlington, Vermont, 05403, United States

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Novartis Investigative Site

Richmond, Virginia, 23219, United States

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Novartis Investigative Site

Richmond, Virginia, 23233, United States

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Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• 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.

  PMID: 28848879 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive; Respiratory Tract Diseases

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 11, 2015
• Results First Posted: March 11, 2015

Record last verified: 2015-03

Locations

US (59)