Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00999908
First received: October 21, 2009
Last updated: August 25, 2011
Last verified: August 2011
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Purpose
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Indacaterol 150 μg Drug: Tiotropium 18 μg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment [ Time Frame: 4 hour period following inhalation of study treatment ] [ Designated as safety issue: No ]During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
Secondary Outcome Measures:
- Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment [ Time Frame: 4 hour period following inhalation of study treatment ] [ Designated as safety issue: No ]FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
- Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment [ Time Frame: 4 hour period following inhalation of study treatment ] [ Designated as safety issue: No ]FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
| Enrollment: | 54 |
| Study Start Date: | October 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Indacaterol 150 μg-tiotropium 18 μg-placebo
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Drug: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
|
|
Experimental: Tiotropium 18 μg-placebo-indacaterol 150 μg
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Drug: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
|
|
Experimental: Placebo-indacaterol 150 μg-tiotropium 18 μg
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Drug: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
- Smoking history of at least 10 pack-years.
- Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
- Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.
Exclusion Criteria:
- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease.
- Patients with alpha-1-antitrypsin deficiency.
- Patients with contraindications for tiotropium treatment.
- Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999908
Locations
| Italy | |
| Novartis Investigative Site | |
| Bergamo, Italy | |
| Novartis Investigative Site | |
| Brescia, Italy | |
| Novartis Investigative Site | |
| Cava De' Tirreni, Italy | |
| Novartis Investigative Site | |
| Genova, Italy | |
| Novartis Investigative Site | |
| Milano, Italy | |
| Novartis Investigative Site | |
| Orbassano, Italy | |
| Novartis Investigative Site | |
| Pavia, Italy | |
| Novartis Investigative Site | |
| Reggio Emilia, Italy | |
| Novartis Investigative Site | |
| Sesto San Giovanni, Italy | |
| Novartis Investigative Site | |
| Treviso, Italy | |
| Novartis Investigative Site | |
| Verona, Italy | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00999908 History of Changes |
| Other Study ID Numbers: | CQAB149BIT01, 2009-013763-19 |
| Study First Received: | October 21, 2009 |
| Results First Received: | July 22, 2011 |
| Last Updated: | August 25, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Novartis:
|
COPD indacaterol tiotropium |
Additional relevant MeSH terms:
|
Respiratory Aspiration Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013