NVA237 Versus Placebo 12-week Efficacy Study

NCT01709864 | Completed Phase 3 Results

• 1 other identifier: CNVA237A2317
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 54

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 of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing

  The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.

  12 weeks

Secondary Outcomes (14)

• Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit

  Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)

• Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)

  Day 1 and Week 12 (Day 85)

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

  Week 12

• Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12

  Week 12

• Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12

  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 (glycopyrronium 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:

• 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).
• 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.
• 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 (54)

Novartis Investigative Site

Homewood, Alabama, 35209-6870, United States

Location

Novartis Investigative Site

Jasper, Alabama, 35501, United States

Location

Novartis Investigative Site

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

Location

Novartis Investigative Site

Tucson, Arizona, 85712, United States

Location

Novartis Investigative Site

Fountain Valley, California, 92708, United States

Location

Novartis Investigative Site

Fullerton, California, 92835, United States

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Novartis Investigative Site

Los Angeles, California, 90048, United States

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Novartis Investigative Site

Los Angeles, California, 90095, United States

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Novartis Investigative Site

Riverside, California, 92506, United States

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Novartis Investigative Site

San Diego, California, 92117-4946, United States

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Novartis Investigative Site

San Diego, California, 92120, United States

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Novartis Investigative Site

Brandon, Florida, 33511, United States

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Novartis Investigative Site

Clearwater, Florida, 33756, United States

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Novartis Investigative Site

DeFuniak Springs, Florida, 32435, United States

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Novartis Investigative Site

Edgewater, Florida, 32132, United States

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Novartis Investigative Site

Fort Lauderdale, Florida, 33306, United States

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Novartis Investigative Site

Hialeah, Florida, 33012, United States

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Novartis Investigative Site

Miami, Florida, 33136, United States

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Novartis Investigative Site

Miami, Florida, 33156, United States

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Novartis Investigative Site

Miami, Florida, 33173, United States

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Novartis Investigative Site

Miami, Florida, 33186, United States

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Novartis Investigative Site

Pensacola, Florida, 32503, United States

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Novartis Investigative Site

Pompano Beach, Florida, 33060, United States

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Novartis Investigative Site

Port Orange, Florida, 32127, United States

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Novartis Investigative Site

Sarasota, Florida, 34233, United States

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Novartis Investigative Site

South Miami, Florida, 33143, United States

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Novartis Investigative Site

Summerfield, Florida, 34491, United States

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Novartis Investigative Site

Tamarac, Florida, 33321, United States

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Novartis Investigative Site

Tampa, Florida, 33603, United States

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Novartis Investigative Site

Winter Park, Florida, 32789, United States

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Novartis Investigative Site

Las Vegas, Nevada, 89104, United States

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Novartis Investigative Site

Las Vegas, Nevada, 89123, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

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Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

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Novartis Investigative Site

Shelby, North Carolina, 28152, United States

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Novartis Investigative Site

Charleston, South Carolina, 29406-7108, United States

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Novartis Investigative Site

Charleston, South Carolina, 29407, United States

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Novartis Investigative Site

Columbia, South Carolina, 29201, United States

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Novartis Investigative Site

Easley, South Carolina, 29640, United States

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Novartis Investigative Site

Gaffney, South Carolina, 29340, United States

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Novartis Investigative Site

Greenville, South Carolina, 29615, United States

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Novartis Investigative Site

Ninety Six, South Carolina, 29666, United States

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Novartis Investigative Site

Rock Hll, South Carolina, 29732, United States

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Novartis Investigative Site

Seneca, South Carolina, 29678, United States

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Novartis Investigative Site

Simpsonville, South Carolina, 29681, United States

Location

Novartis Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

Union, South Carolina, 29379, United States

Location

Novartis Investigative Site

Amarillo, Texas, 79106-4165, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

Arlington, Texas, 76014, United States

Location

Novartis Investigative Site

Beaumont, Texas, 77701, United States

Location

Novartis Investigative Site

Dallas, Texas, 75251, United States

Location

Novartis Investigative Site

Huntsville, Texas, 77340, United States

Location

Novartis Investigative Site

Waco, Texas, 76712, United States

Location

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 16, 2012
• First Posted: October 18, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 4, 2015
• Results First Posted: February 12, 2015

Record last verified: 2015-02

Locations

US (54)