|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00669617 |
Purpose
This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Indacaterol 150 µg Drug: Indacaterol 300 µg Drug: Salmeterol/fluticasone (50/500 μg) Drug: Salbutamol 200 µg Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls |
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Indacaterol 150 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
|
Drug: Indacaterol 150 µg |
|
2: Experimental
Indacaterol 300 µg single dose, delivered via single-dose dry powder inhaler (SDDPI)
|
Drug: Indacaterol 300 µg |
|
3: Active Comparator
Salmeterol/fluticasone (50/500 μg) fixed-dose combination delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
|
Drug: Salmeterol/fluticasone (50/500 μg) |
|
4: Active Comparator
Salbutamol 200 μg delivered via manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI)
|
Drug: Salbutamol 200 µg |
|
5: Placebo Comparator
Placebo delivered via matching devices
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Novartis Investigative Site | |
| Tamarac, Florida, United States, 33321 | |
| United States, Louisiana | |
| Novartis Investigator Site | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Missouri | |
| Novartis Investigative Site | |
| St Charles, Missouri, United States, 63301-2847 | |
| United States, North Carolina | |
| Novartis Investigative site | |
| Shelby, North Carolina, United States, 28150 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | |
| Beaver, Pennsylvania, United States, 15009 | |
| Belgium | |
| Novartis Investigative Site | |
| Antwerpen, Belgium | |
| Germany | |
| Novartis Investigative site | |
| Hamburg, Germany | |
| Novartis Investigative site | |
| Hannover, Germany | |
| Novartis Investigative site | |
| Dortmund, Germany | |
| Novartis Investigative site | |
| Wiesbaden, Germany | |
| Novartis Investigative site | |
| Mainz, Germany | |
| Novartis Investigative Site | |
| Berlin, Germany | |
| Novartis Investigator Site | |
| Potsdam, Germany | |
| Novartis Investigative Site | |
| Hamburg, Germany | |
| Novartis Investigator Site | |
| Borstel, Germany | |
| Hungary | |
| Novartis Investigative site | |
| Debrecen, Hungary | |
| Novartis Investigative site | |
| Deszk, Hungary | |
| Novartis Investigative Site | |
| Nyiregyhaza, Hungary | |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CQAB149B2307, EUDRACT: 2007-006189-14 |
| Study First Received: | April 28, 2008 |
| Last Updated: | November 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00669617 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; United States: Food and Drug Administration |
|
chronic obstructive pulmonary disease COPD indacaterol adults |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Albuterol Reproductive Control Agents Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents Therapeutic Uses |
Fluticasone Dermatologic Agents Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |