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A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

NCT ID: NCT01005901

Last Updated: 2012-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glycopyrronium bromide

Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Group Type EXPERIMENTAL

Glycopyrronium bromide

Intervention Type DRUG

Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)

Placebo

Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo inhalation capsules were provided for use via a SDDPI

Interventions

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Glycopyrronium bromide

Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)

Intervention Type DRUG

Placebo

Placebo inhalation capsules were provided for use via a SDDPI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

* Smoking history of at least 10 pack-years
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria

1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
2. Patients with concomitant pulmonary disease
3. Patients with a history of asthma
4. Any patient with lung cancer or a history of lung cancer
5. Patients with a history of certain cardiovascular comorbid conditions
6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
7. Patients in the active phase of a supervised pulmonary rehabilitation program
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

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

Birmingham, Alabama, United States

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Fairhope, Alabama, United States

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Glendale, Arizona, United States

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Los Angeles, California, United States

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Walnut Creek, California, United States

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Newark, Delaware, United States

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Port Orange, Florida, United States

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Tamarac, Florida, United States

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Topeka, Kansas, United States

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Madisonville, Kentucky, United States

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Slidell, Louisiana, United States

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Biddeford, Maine, United States

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Pikesville, Maryland, United States

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Ann Arbor, Michigan, United States

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Livonia, Michigan, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Saint Charles, Missouri, United States

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Missoula, Montana, United States

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Bellevue, Nebraska, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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New Brunswick, New Jersey, United States

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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Lincoln, Rhode Island, United States

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Johnson City, Tennessee, United States

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Corpus Christi, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Daw Park SA, , Australia

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Bridgewater, Nova Scotia, Canada

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Courtice, Ontario, Canada

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Mississuaga, Ontario, Canada

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North York, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Asahikawa, , Japan

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Hamakita, , Japan

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Himeji, , Japan

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Hitachi, , Japan

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Kishiwada, , Japan

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Kyoto, , Japan

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Matsue, , Japan

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Matsusaka, , Japan

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Moriya, , Japan

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Naka-gun, , Japan

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Obihiro, , Japan

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Osaka, , Japan

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Ōta-ku, , Japan

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Ōtsu, , Japan

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Sapporo, , Japan

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Takatsuki, , Japan

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Tokyo, , Japan

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Yabu, , Japan

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Yonezawa, , Japan

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Almelo, , Netherlands

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Eindhoven, , Netherlands

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Harderwijk, , Netherlands

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Heerlen, , Netherlands

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Zutphen, , Netherlands

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Bucharest, , Romania

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Iași, , Romania

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Timișoara, , Romania

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Irkutsk, , Russia

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Kazan', , Russia

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Krasnodar, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Sochy, , Russia

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Stavropol, , Russia

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Yaroslavl, , Russia

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Singapore, , Singapore

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Daegu, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Alicante, , Spain

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Badalona, , Spain

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Canet de Mar, , Spain

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Cáceres, , Spain

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Centelles, , Spain

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Valencia, , Spain

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Altunizade, , Turkey (Türkiye)

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Aydin, , Turkey (Türkiye)

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Diyarbakır, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kinikli/Denizli, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Soke/Aydin, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Countries

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United States Australia Canada Japan Netherlands Romania Russia Singapore South Korea Spain Turkey (Türkiye)

References

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D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, Lu Y, Banerji D, Overend T. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011 Dec 7;12(1):156. doi: 10.1186/1465-9921-12-156.

Reference Type RESULT
PMID: 22151296 (View on PubMed)

D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.

Reference Type DERIVED
PMID: 24156566 (View on PubMed)

Other Identifiers

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2009-013504-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNVA237A2304

Identifier Type: -

Identifier Source: org_study_id

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