Back to resultsEffect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
Primary Purpose
COPD
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Indacaterol (QAB149)
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring inspiratory capacity, FEV1, COPD
Eligibility Criteria
Inclusion Criteria:
- Male and post-menopausal female adults aged 40-80 years inclusive.
- Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)
- Smoking history of at least 10 pack years (either smokers or ex-smokers).
- Able to perform reproducible spirometry maneuvers.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Exclusion Criteria:
- COPD exacerbations within 6 weeks prior to dosing
- Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
- Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
- Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative site
Outcomes
Primary Outcome Measures
Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours
Secondary Outcome Measures
Percent predicted FEV1 time course change over 24 hours
Mean maximal change in IC time course change over 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00422552
Brief Title
Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
Official Title
An Exploratory, Double-Blind Comparison of Inspiratory Capacity (IC) and FEV1 in COPD Patients Following Single Dose Administration of Indacaterol and Placebo and Open Label b.i.d. Administration of Formoterol
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
inspiratory capacity, FEV1, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indacaterol (QAB149)
Primary Outcome Measure Information:
Title
Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours
Secondary Outcome Measure Information:
Title
Percent predicted FEV1 time course change over 24 hours
Title
Mean maximal change in IC time course change over 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and post-menopausal female adults aged 40-80 years inclusive.
Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)
Smoking history of at least 10 pack years (either smokers or ex-smokers).
Able to perform reproducible spirometry maneuvers.
Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Exclusion Criteria:
COPD exacerbations within 6 weeks prior to dosing
Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Investigative site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative site
City
Horsham
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
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