Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma

Not Applicable

Completed

• Conditions: Allergic Asthma
• Interventions: Drug: Salmeterol and Salmeterol / Fluticasone

• Registration Number: NCT00736801
• Lead Sponsor: University of Rostock

Brief Summary

BDNF has been linked to the pathogenesis of airway hyperresponsiveness in asthma. In this trial, the impact of a treatment with salmeterol and salmeterol / fluticasone on BDNF concentrations will be assessed in patients with asthma. The investigators hypothesize that salmeterol impacts on BDNF concentrations in patients with asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-01
• Study Completion: 2007-04
• Status Verified: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Age > 18 years, a physician's diagnosis of allergic asthma
• A documented sensitization to aero-allergens (pollen, animal hair, or house dust mite)
• A pre-bronchodilator forced expiratory volume in the first second (FEV1) > 80 % of the predicted value (% predicted), a provocative concentration of histamine causing a 20 % fall in FEV1 (PC20) of < 8 mg histamine / ml

Exclusion Criteria

• No regular treatment (only short-acting inhalers on demand were allowed)
• No history of or evidence for any other chronic disease than asthma
• No history of smoking, absence of any signs or symptoms of an infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Salmeterol and Salmeterol / Fluticasone	Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks.

Primary Outcome Measures

Name	Time	Method
BDNF concentrations in serum, platelets and plasma	2006 - 2007

Secondary Outcome Measures

Name	Time	Method
Airway hyperresponsiveness	2006 - 2007

Trial Locations

Locations (1)

University of Rostock; 🇩🇪 Rostock, Germany