Back to resultsInfluence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
formoterol (TURBOHALER)
Salmeterol (DISKUS)
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Salmeterol, Formoterol, Airway resistance
Eligibility Criteria
Inclusion criteria: Asthma Reversibility >15% and 200 ml in total FEV1 <85% of normal Exclusion criteria: Smoking history >20 pack years Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication
Secondary Outcome Measures
Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327353
Brief Title
Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol
Official Title
Single-Centre Randomised Open Crossover Study to Examine the Influence of Different Internal Resistances of Discus and Turbohaler Respectively on the Effects of Salmeterol and Formoterol in Asthmatic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Salmeterol, Formoterol, Airway resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
formoterol (TURBOHALER)
Intervention Type
Drug
Intervention Name(s)
Salmeterol (DISKUS)
Other Intervention Name(s)
formoterol (TURBOHALER)
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication
Secondary Outcome Measure Information:
Title
Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Asthma Reversibility >15% and 200 ml in total FEV1 <85% of normal
Exclusion criteria:
Smoking history >20 pack years Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol
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