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

NCT01005901 | Completed Phase 3 Results

• 2 other identifiers: CNVA237A23042009-013504-32
• Study Type: interventional
• Target: 1,324
• Locations: 11 countries
• Sites: 96

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; NVA; FEV1

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks

  Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.

  12 weeks

Secondary Outcomes (16)

• Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment

  26 weeks

• Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment

  26 weeks

• Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment

  26 weeks

• Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)

  26 weeks

• FEV1 at Each Time-point on Day 1 and Week 26

  Day 1 and Week 26

Study Arms (2)

Glycopyrronium bromide

EXPERIMENTAL

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.

Drug: Glycopyrronium bromide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Glycopyrronium bromide DRUG

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

Glycopyrronium bromide

Placebo DRUG

Placebo inhalation capsules were provided for use via a SDDPI

Placebo

Eligibility Criteria

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

You may qualify if:

• \. 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%

You may not qualify if:

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

Sponsors & Collaborators

• Novartis: lead

Study Sites (96)

Novartis Investigative Site

Birmingham, Alabama, United States

Location

Novartis Investigative Site

Fairhope, Alabama, United States

Location

Novartis Investigative Site

Glendale, Arizona, United States

Location

Novartis Investigative Site

Los Angeles, California, United States

Location

Novartis Investigative Site

Walnut Creek, California, United States

Location

Novartis Investigative Site

Newark, Delaware, United States

Location

Novartis Investigative Site

Port Orange, Florida, United States

Location

Novartis Investigative Site

Tamarac, Florida, United States

Location

Novartis Investigative Site

Topeka, Kansas, United States

Location

Novartis Investigative Site

Madisonville, Kentucky, United States

Location

Novartis Investigative Site

Slidell, Louisiana, United States

Location

Novartis Investigative Site

Biddeford, Maine, United States

Location

Novartis Investigative Site

Pikesville, Maryland, United States

Location

Novartis Investigative Site

Ann Arbor, Michigan, United States

Location

Novartis Investigative Site

Livonia, Michigan, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, United States

Location

Novartis Investigative Site

Kansas City, Missouri, United States

Location

Novartis Investigative Site

Saint Charles, Missouri, United States

Location

Novartis Investigative Site

Missoula, Montana, United States

Location

Novartis Investigative Site

Bellevue, Nebraska, United States

Location

Novartis Investigative Site

Omaha, Nebraska, United States

Location

Novartis Investigative Site

Reno, Nevada, United States

Location

Novartis Investigative Site

New Brunswick, New Jersey, United States

Location

Novartis Investigative Site

Rochester, New York, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Location

Novartis Investigative Site

Tulsa, Oklahoma, United States

Location

Novartis Investigative Site

Lincoln, Rhode Island, United States

Location

Novartis Investigative Site

Johnson City, Tennessee, United States

Location

Novartis Investigative Site

Corpus Christi, Texas, United States

Location

Novartis Investigative Site

McKinney, Texas, United States

Location

Novartis Investigative Site

San Antonio, Texas, United States

Location

Novartis Investigative Site

Richmond, Virginia, United States

Location

Novartis Investigative Site

Daw Park SA, Australia

Location

Novartis Investigative Site

Bridgewater, Nova Scotia, Canada

Location

Novartis Investigative Site

Courtice, Ontario, Canada

Location

Novartis Investigative Site

Mississuaga, Ontario, Canada

Location

Novartis Investigative Site

North York, Ontario, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, Canada

Location

Novartis Investigative Site

Toronto, Ontario, Canada

Location

Novartis Investigative Site

Montreal, Quebec, Canada

Location

Novartis Investigative Site

Asahikawa, Japan

Location

Novartis Investigative Site

Hamakita, Japan

Location

Novartis Investigative Site

Himeji, Japan

Location

Novartis Investigative Site

Hitachi, Japan

Location

Novartis Investigative Site

Kishiwada, Japan

Location

Novartis Investigative Site

Kyoto, Japan

Location

Novartis Investigative Site

Matsue, Japan

Location

Novartis Investigative Site

Matsusaka, Japan

Location

Novartis Investigative Site

Moriya, Japan

Location

Novartis Investigative Site

Naka-gun, Japan

Location

Novartis Investigative Site

Obihiro, Japan

Location

Novartis Investigative Site

Osaka, Japan

Location

Novartis Investigative Site

Ōta-ku, Japan

Location

Novartis Investigative Site

Ōtsu, Japan

Location

Novartis Investigative Site

Sapporo, Japan

Location

Novartis Investigative Site

Takatsuki, Japan

Location

Novartis Investigative Site

Tokyo, Japan

Location

Novartis Investigative Site

Yabu, Japan

Location

Novartis Investigative Site

Yonezawa, Japan

Location

Novartis Investigative Site

Almelo, Netherlands

Location

Novartis Investigative Site

Eindhoven, Netherlands

Location

Novartis Investigative Site

Harderwijk, Netherlands

Location

Novartis Investigative Site

Heerlen, Netherlands

Location

Novartis Investigative Site

Zutphen, Netherlands

Location

Novartis Investigative Site

Bucharest, Romania

Location

Novartis Investigative Site

Iași, Romania

Location

Novartis Investigative Site

Timișoara, Romania

Location

Novartis Investigative Site

Irkutsk, Russia

Location

Novartis Investigative Site

Kazan', Russia

Location

Novartis Investigative Site

Krasnodar, Russia

Location

Novartis Investigative Site

Moscow, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, Russia

Location

Novartis Investigative Site

Novosibirsk, Russia

Location

Novartis Investigative Site

Sochy, Russia

Location

Novartis Investigative Site

Stavropol, Russia

Location

Novartis Investigative Site

Yaroslavl, Russia

Location

Novartis Investigative Site

Singapore, Singapore

Location

Novartis Investigative Site

Daegu, South Korea

Location

Novartis Investigative Site

Pusan, South Korea

Location

Novartis Investigative site

Seoul, South Korea

Location

Novartis Investigative Site

Alicante, Spain

Location

Novartis Investigative Site

Badalona, Spain

Location

Novartis Investigative Site

Canet de Mar, Spain

Location

Novartis Investigative Site

Cáceres, Spain

Location

Novartis Investigative Site

Centelles, Spain

Location

Novartis Investigative Site

Valencia, Spain

Location

Novartis Investigative Site

Altunizade, Turkey (Türkiye)

Location

Novartis Investigative Site

Aydin, Turkey (Türkiye)

Location

Novartis Investigative Site

Diyarbakır, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Location

Novartis Investigative Site

Kinikli/Denizli, Turkey (Türkiye)

Location

Novartis Investigative Site

Mersin, Turkey (Türkiye)

Location

Novartis Investigative Site

Soke/Aydin, Turkey (Türkiye)

Location

Novartis Investigative Site

Yenisehir/Izmir, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 22151296 RESULT

• 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.

  PMID: 24156566 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: October 30, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 12, 2012
• Results First Posted: April 12, 2012

Record last verified: 2011-12

Locations

NL (5); KR (3); SG (1); US (33); ES (6); JP (19); CA (7); RU (9); TU (9); AU (1); RO (3)