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Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

NCT ID: NCT01697696

Last Updated: 2016-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NVA237 dose 1

NVA237 dose 1

Group Type EXPERIMENTAL

NVA237

Intervention Type DRUG

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

Long-acting beta 2-agonist (LABA)

QAB149

Group Type ACTIVE_COMPARATOR

Long-acting beta 2-agonist (LABA)

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo to match QAB149

Interventions

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NVA237

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

Intervention Type DRUG

Long-acting beta 2-agonist (LABA)

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

Intervention Type DRUG

Placebo

Placebo to match QAB149

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Gulf Shores, Alabama, United States

Site Status

Novartis Investigative Site

Mobile, Alabama, United States

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Tucson, Arizona, United States

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Riverside, California, United States

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Novartis Investigative Site

Fort Collins, Colorado, United States

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Novartis Investigative Site

Wheat Ridge, Colorado, United States

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Novartis Investigative Site

Glastonbury, Connecticut, United States

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Novartis Investigative Site

Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Clearwater, 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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Oakland Park, Florida, United States

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Pensacola, Florida, United States

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Couer D'Alene, Idaho, United States

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Newburgh, Indiana, United States

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Topeka, Kansas, United States

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Florence, Kentucky, United States

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Madisonville, Kentucky, United States

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New Orleans, Louisiana, United States

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Opelousas, Louisiana, United States

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Biddeford, Maine, United States

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Worchester, Massachusetts, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Fremont, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Calabash, North Carolina, United States

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Tabor City, North Carolina, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Marion, Ohio, United States

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Zanesville, Ohio, United States

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Eugene, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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North Myrtle Beach, South Carolina, United States

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Boerne, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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Novartis Investigative Site

San Antonio, Texas, United States

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Novartis Investigative Site

White River Junction, Vermont, United States

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Novartis Investigative Site

Burke, Virginia, United States

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Novartis Investigative Site

Fredericksburg, Virginia, United States

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Novartis Investigative Site

Manassas, Virginia, United States

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Novartis Investigative Site

Richmond, Virginia, United States

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Novartis Investigative Site

Richmond, Virginia, United States

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Novartis Investigative Site

Oregon, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27215502 (View on PubMed)

Other Identifiers

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2012-002728-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNVA237A2319

Identifier Type: -

Identifier Source: org_study_id

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