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NCT00327353 Clinical Trial

Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00327353
Other study ID # 101182
Secondary ID TURBOHALER Fakto
Status Completed
Phase Phase 4
First received May 16, 2006
Last updated May 21, 2009
Start date January 2004

Study information
Verified date May 2009
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• formoterol (TURBOHALER)

• Salmeterol (DISKUS)

Locations
Country Name City State
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Gauting Bayern

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication
Secondary Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug
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