Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624286
• Other study ID #: CQAB149B2346
• Secondary ID: EUDRACT Number:
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2008
• Last updated: July 22, 2011
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIndia: Institutional Review BoardItaly: National Bioethics CommitteeLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Singapore: Health Sciences AuthoritySweden: Medical Products AgencyTaiwan: Department of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus

• 20 pack-year smoking history

• Signed informed consent

• Post-bronchodilator forced expiratory volume in 1 second )FEV1) = 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria include:

• History of asthma

• Prior exposure to indacaterol

• Active cancer or history of cancer

• Patients with concomitant pulmonary disease

• Patients with diabetes Type I or uncontrolled diabetes Type II

• Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged

• Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol 150 µg
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
• Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Lanaken
New Zealand	Novartis Investigator Site	Tauranga
United States	Novartis Investigative Site	Abingdon	Virginia
United States	Novartis Investigative Site	Amarillo	Texas
United States	Novartis Investigative Site	Ames	Iowa
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Austell	Georgia
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Buena Park	California
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cherry Hill	New Jersey
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigator Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Clarkston	Michigan
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Cortland	New York
United States	Novartis Investigative Site	Crescent springs	Kentucky
United States	Novartis Investigative Site	Cumberland	Rhode Island
United States	Novartis Investigator Site	Edina	Minnesota
United States	Novartis Investigative Site	El Paso	Texas
United States	Novartis Investigative Site	Encinitas	California
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Flint	Michigan
United States	Novartis Investigative Site	Fort Collins	Colorado
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Ft. Worth	Texas
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Gaffney	South Carolina
United States	Novartis Investigator Site	Glendale	Arizona
United States	Novartis Investigative Site	Golden	Colorado
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Homestead	Pennsylvania
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Jasper	Alabama
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative Site	Kalispell	Montana
United States	Novartis Investigative Site	Largo	Florida
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Livonia	Michigan
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Lynchburg	Virginia
United States	Novartis Investigative Site	Madisonville	Kentucky
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Morgantown	West Virginia
United States	Novartis Investigative Site	N. Charleston	South Carolina
United States	Novartis Investigative Site	New braunfels	Texas
United States	Novartis Investigative Site	Newark	Delaware
United States	Novartis Investigative Site	Normal	Illinois
United States	Novartis Investigative Site	O fallon	Illinois
United States	Novartis Investigative Site	Ocala	Florida
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Opelousas	Louisiana
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Palmdale	California
United States	Novartis Investigative Site	Payson	Utah
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Pine Bluff	Arkansas
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	River Forest	Illinois
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Rockledge	Florida
United States	Novartis Investigator Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	San Mateo	California
United States	Novartis Investigator Site	Sarasota	Florida
United States	Novartis Investigative Site	Shawnee	Kansas
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	Slidell	Louisiana
United States	Novartis Investigative Site	South Miami	Florida
United States	Novartis Investigative Site	Spartanburg	South Carolina
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Spokane Valley	Washington
United States	Novartis Investigative Site	St Charles	Missouri
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Summit	New Jersey
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Thornville	Ohio
United States	Novartis Investigative Site	Torrance	California
United States	Novartis Investigative Site	Troy	Michigan
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Union	South Carolina
United States	Novartis Investigative Site	Vista	California
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigator Site	Wheat Ridge	Colorado
United States	Novartis Investigative Site	Worcester	Massachusetts
United States	Novartis Investigative Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.	24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.	24 hours post-dose on Day 2	No