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

A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Sponsors

Lead Sponsor: Novartis

Source Novartis
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).

Overall Status Completed
Start Date October 2009
Completion Date December 2010
Primary Completion Date December 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks 12 weeks
Secondary Outcome
Measure Time Frame
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
Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26 Day 1 and Week 26
FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26 Day 1, Week 12 and Week 26
FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26 Week 12 and Week 26
Trough FEV1 and FVC at Day 1 and Week 26 Day 1 and Week 26
Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26 Baseline, Day 1, Week 12 and Week 26
Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations 26 Weeks and 30 Day follow-up
Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period 26 weeks
Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period 26 Weeks
Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period 26 Weeks
Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period 26 Weeks
Mean Daily Total Symptom Score Over the 26 Week Treatment Period 26 Weeks
Enrollment 1324
Condition
Intervention

Intervention Type: Drug

Intervention Name: Glycopyrronium bromide

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

Arm Group Label: Glycopyrronium bromide

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo inhalation capsules were provided for use via a SDDPI

Arm Group Label: Placebo

Eligibility

Criteria:

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

8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Location
Facility:
Novartis Investigative Site | Birmingham, Alabama, United States
Novartis Investigative Site | Fairhope, Alabama, United States
Novartis Investigative Site | Glendale, Arizona, United States
Novartis Investigative Site | Los Angeles, California, United States
Novartis Investigative Site | Walnut Creek, California, United States
Novartis Investigative Site | Newark, Delaware, United States
Novartis Investigative Site | Port Orange, Florida, United States
Novartis Investigative Site | Tamarac, Florida, United States
Novartis Investigative Site | Topeka, Kansas, United States
Novartis Investigative Site | Madisonville, Kentucky, United States
Novartis Investigative Site | Slidell, Louisiana, United States
Novartis Investigative Site | Biddeford, Maine, United States
Novartis Investigative Site | Pikesville, Maryland, United States
Novartis Investigative Site | Ann Arbor, Michigan, United States
Novartis Investigative Site | Livonia, Michigan, United States
Novartis Investigative Site | Minneapolis, Minnesota, United States
Novartis Investigative Site | Kansas City, Missouri, United States
Novartis Investigative Site | St. Charles, Missouri, United States
Novartis Investigative Site | Missoula, Montana, United States
Novartis Investigative Site | Bellevue, Nebraska, United States
Novartis Investigative Site | Omaha, Nebraska, United States
Novartis Investigative Site | Reno, Nevada, United States
Novartis Investigative Site | New Brunswick, New Jersey, United States
Novartis Investigative Site | Rochester, New York, United States
Novartis Investigative Site | Cincinnati, Ohio, United States
Novartis Investigative Site | Oklahoma City, Oklahoma, United States
Novartis Investigative Site | Tulsa, Oklahoma, United States
Novartis Investigative Site | Lincoln, Rhode Island, United States
Novartis Investigative Site | Johnson City, Tennessee, United States
Novartis Investigative Site | Corpus Christi, Texas, United States
Novartis Investigative Site | McKinney, Texas, United States
Novartis Investigative Site | San Antonio, Texas, United States
Novartis Investigative Site | Richmond, Virginia, United States
Novartis Investigative Site | Daw Park SA, Australia
Novartis Investigative Site | Bridgewater, Nova Scotia, Canada
Novartis Investigative Site | Courtice, Ontario, Canada
Novartis Investigative Site | Mississuaga, Ontario, Canada
Novartis Investigative Site | North York, Ontario, Canada
Novartis Investigative Site | Ottawa, Ontario, Canada
Novartis Investigative Site | Toronto, Ontario, Canada
Novartis Investigative Site | Montreal, Quebec, Canada
Novartis Investigative Site | Asahikawa, Japan
Novartis Investigative Site | Hamakita, Japan
Novartis Investigative Site | Himeji, Japan
Novartis Investigative Site | Hitachi, Japan
Novartis Investigative Site | Kishiwada, Japan
Novartis Investigative Site | Kyoto, Japan
Novartis Investigative Site | Matsue, Japan
Novartis Investigative Site | Matsusaka, Japan
Novartis Investigative Site | Moriya, Japan
Novartis Investigative Site | Naka-gun, Japan
Novartis Investigative Site | Obihiro, Japan
Novartis Investigative Site | Osaka, Japan
Novartis Investigative Site | Ota, Japan
Novartis Investigative Site | Otsu, Japan
Novartis Investigative Site | Sapporo, Japan
Novartis Investigative Site | Takatsuki, Japan
Novartis Investigative Site | Tokyo, Japan
Novartis Investigative Site | Yabu, Japan
Novartis Investigative Site | Yonezawa, Japan
Novartis Investigative Site | Daegu, Korea, Republic of
Novartis Investigative Site | Pusan, Korea, Republic of
Novartis Investigative site | Seoul, Korea, Republic of
Novartis Investigative Site | Almelo, Netherlands
Novartis Investigative Site | Eindhoven, Netherlands
Novartis Investigative Site | Harderwijk, Netherlands
Novartis Investigative Site | Heerlen, Netherlands
Novartis Investigative Site | Zutphen, Netherlands
Novartis Investigative Site | Bucharest, Romania
Novartis Investigative Site | Bucuresti, Romania
Novartis Investigative Site | Iasi, Romania
Novartis Investigative Site | Timisoara, Romania
Novartis Investigative Site | Irkutsk, Russian Federation
Novartis Investigative Site | Kazan, Russian Federation
Novartis Investigative Site | Krasnodar, Russian Federation
Novartis Investigative Site | Moscow, Russian Federation
Novartis Investigative Site | N. Novgorod, Russian Federation
Novartis Investigative Site | Novosibirsk, Russian Federation
Novartis Investigative Site | Sochy, Russian Federation
Novartis Investigative Site | Stavropol, Russian Federation
Novartis Investigative Site | Yaroslavl, Russian Federation
Novartis Investigative Site | Singapore, Singapore
Novartis Investigative Site | Alicante, Spain
Novartis Investigative Site | Badalona, Spain
Novartis Investigative Site | Caceres, Spain
Novartis Investigative Site | Canet de Mar, Spain
Novartis Investigative Site | Centelles, Spain
Novartis Investigative Site | Valencia, Spain
Novartis Investigative Site | Altunizade, Turkey
Novartis Investigative Site | Aydin, Turkey
Novartis Investigative Site | Diyarbakir, Turkey
Novartis Investigative Site | Istanbul, Turkey
Novartis Investigative Site | Izmir, Turkey
Novartis Investigative Site | Kinikli/Denizli, Turkey
Novartis Investigative Site | Mersin, Turkey
Novartis Investigative Site | Soke/Aydin, Turkey
Novartis Investigative Site | Yenisehir/Izmir, Turkey
Location Countries

Australia

Canada

Japan

Korea, Republic of

Netherlands

Romania

Russian Federation

Singapore

Spain

Turkey

United States

Verification Date

December 2011

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Glycopyrronium bromide

Type: Experimental

Description: 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.

Label: Placebo

Type: Placebo Comparator

Description: 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.

Acronym GLOW 1
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov