Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol
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
2 other identifiers
interventional
77
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedMay 22, 2009
May 1, 2009
May 16, 2006
May 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication
Secondary Outcomes (1)
Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug
Interventions
Eligibility Criteria
You may qualify if:
- Asthma Reversibility \>15% and 200 ml in total FEV1 \<85% of normal
You may not qualify if:
- Smoking history \>20 pack years Treatment with ICS \>500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Gauting, Bavaria, 82131, Germany
GSK Investigational Site
Berlin, State of Berlin, 14057, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 16, 2006
First Posted
May 18, 2006
Study Start
January 1, 2004
Last Updated
May 22, 2009
Record last verified: 2009-05