Back to resultsIndacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
indacaterol maleate
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring indacaterol, long acting beta agonist
Eligibility Criteria
Inclusion Criteria:
- Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
- Smoking history of at least 10 pack years
- FEV1 less than 65% of the predicted normal value and at least 0.75 L
- Pre-bronchodilator FEV1/FVC less than 70%
Exclusion Criteria:
- A history of asthma or COPD diagnosis before the age of 40
- Hospitalization for COPD exacerbation within the previous 6 weeks
- Respiratory tract infection within 6 weeks
- Use of long-term oxygen therapy
- Diabetes type I or uncontrolled diabetes type II
- Clinically relevant laboratory abnormality or clinically significant condition
- Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
Secondary Outcome Measures
FEV1 at time points 30 min, 1, 2 and 4hours post-dose
Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose
Standardized FEV1 area under the curve (AUC) between baseline and 4 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00396604
Brief Title
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler vs. Placebo in Patients With Moderate to Severe COPD.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive
Keywords
indacaterol, long acting beta agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
indacaterol maleate
Primary Outcome Measure Information:
Title
Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)
Secondary Outcome Measure Information:
Title
FEV1 at time points 30 min, 1, 2 and 4hours post-dose
Title
Percent change in FEV1 at time points 30 min, 1, 2 and 4 hours, 23 hours 10min and 23 hours 45 min post dose
Title
Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 hours, 23 hours 10 min and 23 hours 45 min post dose
Title
Standardized FEV1 area under the curve (AUC) between baseline and 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
Smoking history of at least 10 pack years
FEV1 less than 65% of the predicted normal value and at least 0.75 L
Pre-bronchodilator FEV1/FVC less than 70%
Exclusion Criteria:
A history of asthma or COPD diagnosis before the age of 40
Hospitalization for COPD exacerbation within the previous 6 weeks
Respiratory tract infection within 6 weeks
Use of long-term oxygen therapy
Diabetes type I or uncontrolled diabetes type II
Clinically relevant laboratory abnormality or clinically significant condition
Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis
City
Vilvoorde
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21184620
Citation
Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.
Results Reference
derived
Learn more about this trial
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
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