Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

NCT01697696 | Completed Phase 3 Results

• 2 other identifiers: CNVA237A23192012-002728-34
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 61

Brief Summary

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, NVA237, QAB149, glycopyrronium bromide

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate

  Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.

  52 weeks

Secondary Outcomes (8)

• Time to Treatment Discontinuation

  52 Weeks

• Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52

  -45 min and -15 minutes baseline and at Week 52

• Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints

  -45 min and -15 minutes baseline and at Week 52

• Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints

  -45 min and -15 minutes baseline and at Week 52

• Change From Baseline in COPD Symptoms

  52 weeks

Study Arms (2)

NVA237 dose 1

EXPERIMENTAL

NVA237 dose 1

Drug: NVA237

Long-acting beta 2-agonist (LABA)

ACTIVE COMPARATOR

QAB149

Drug: Long-acting beta 2-agonist (LABA); Drug: Placebo

Interventions

NVA237 DRUG

NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI

NVA237 dose 1

Long-acting beta 2-agonist (LABA) DRUG

QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI

Long-acting beta 2-agonist (LABA)

Placebo DRUG

Placebo to match QAB149

Long-acting beta 2-agonist (LABA)

Eligibility Criteria

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

You may qualify if:

• Male or female patients with COPD according to GOLD 2011 who have signed informed consent.
• Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.
• Current or ex-smokers with a smoking history of at least 10 pack years
• Patients with a mMRC score of at least 2 at run-in.

You may not qualify if:

• Patients contraindicated for muscarinic antagonist agents and beta-2 agonists
• Patients with a history of malignancy of any organ system, treated or untreated, within the last five years
• Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention
• Patients who had a COPD exacerbation within 6 weeks prior to screening.
• Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
• Patients with a history of asthma.
• Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.
• Patients with a blood eosinophil count of greater than 600 mm/3 during run-in
• Patients with concomitant pulmonary disease
• Patients with a history of certain cardiovascular co-morbid conditions
• Patients with a diagnosis of alpha-1 anti-trypsin deficiency
• Patients with active pulmonary tuberculosis
• Patients in the active phase of a pulmonary rehabilitation programme

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (61)

Novartis Investigative Site

Gulf Shores, Alabama, 36547, United States

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Novartis Investigative Site

Mobile, Alabama, 36608, United States

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Tucson, Arizona, 85712, United States

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Riverside, California, 92506, United States

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Fort Collins, Colorado, 80528, United States

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Wheat Ridge, Colorado, 80033, United States

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Glastonbury, Connecticut, 06033, United States

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Stamford, Connecticut, 06902, United States

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Waterbury, Connecticut, 06708, United States

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Clearwater, Florida, 33765, United States

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Hialeah, Florida, 33016, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33172, United States

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Miami, Florida, 33175, United States

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Oakland Park, Florida, 33334, United States

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Pensacola, Florida, 32503, United States

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Couer D'Alene, Idaho, 83814, United States

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Newburgh, Indiana, 47630, United States

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Topeka, Kansas, 66606, United States

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Florence, Kentucky, 41042, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70119, United States

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Opelousas, Louisiana, 70570, United States

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Biddeford, Maine, 04005, United States

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Worchester, Massachusetts, 01608, United States

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Edina, Minnesota, 55435, United States

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Fridley, Minnesota, 55432, United States

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Minneapolis, Minnesota, 55402, United States

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Minneapolis, Minnesota, 55407, United States

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Fremont, Nebraska, 68025, United States

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Omaha, Nebraska, 68134, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Lebanon, New Hampshire, 03756, United States

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Calabash, North Carolina, 28467, United States

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Tabor City, North Carolina, 28463, United States

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Columbus, Ohio, 43215, United States

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Novartis Investigative Site

Columbus, Ohio, 43235, United States

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Novartis Investigative Site

Marion, Ohio, 43302, United States

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Zanesville, Ohio, 43701, United States

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Eugene, Oregon, 97404-3233, United States

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Philadelphia, Pennsylvania, 19140, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29412, United States

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Columbia, South Carolina, 29204, United States

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Greenville, South Carolina, 29605, United States

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Greer, South Carolina, 29651, United States

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North Myrtle Beach, South Carolina, 29582, United States

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Boerne, Texas, 78006, United States

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Novartis Investigative Site

El Paso, Texas, 79902, United States

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Novartis Investigative Site

Houston, Texas, 77043, United States

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Novartis Investigative Site

Houston, Texas, 77081, United States

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Novartis Investigative Site

Kingwood, Texas, 77339, United States

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Novartis Investigative Site

San Antonio, Texas, 78229, United States

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Novartis Investigative Site

White River Junction, Vermont, 05009, United States

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Novartis Investigative Site

Burke, Virginia, 22015, United States

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Novartis Investigative Site

Fredericksburg, Virginia, 22401, United States

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Novartis Investigative Site

Manassas, Virginia, 20110, United States

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Novartis Investigative Site

Richmond, Virginia, 23225, United States

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Novartis Investigative Site

Richmond, Virginia, 23229, United States

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Novartis Investigative Site

Oregon, Wisconsin, 53575, United States

Location

Related Publications (1)

• Mahler DA, Gifford AH, Satti A, Jessop N, Eckert JH, D'Andrea P, Mota F, Banerjee R. Long-term safety of glycopyrrolate: A randomized study in patients with moderate-to-severe COPD (GEM3). Respir Med. 2016 Jun;115:39-45. doi: 10.1016/j.rmed.2016.03.015. Epub 2016 Mar 22.

  PMID: 27215502 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 16, 2016
• Results First Posted: March 16, 2016

Record last verified: 2016-02

Locations

US (61)