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

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Salmeterol and Salmeterol / Fluticasone
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Asthma focused on measuring Airway hyperresponsiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rostock

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks.

Outcomes

Primary Outcome Measures

BDNF concentrations in serum, platelets and plasma

Secondary Outcome Measures

Airway hyperresponsiveness

Full Information

First Posted
August 15, 2008
Last Updated
August 20, 2008
Sponsor
University of Rostock
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00736801
Brief Title
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma
Official Title
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rostock
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
Airway hyperresponsiveness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Salmeterol and Salmeterol / Fluticasone
Other Intervention Name(s)
Serevent, Viani
Intervention Description
Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.
Primary Outcome Measure Information:
Title
BDNF concentrations in serum, platelets and plasma
Time Frame
2006 - 2007
Secondary Outcome Measure Information:
Title
Airway hyperresponsiveness
Time Frame
2006 - 2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann C. Virchow, MD, FCCP
Organizational Affiliation
University of Rostock
Official's Role
Study Chair
Facility Information:
Facility Name
University of Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15516533
Citation
Lommatzsch M, Schloetcke K, Klotz J, Schuhbaeck K, Zingler D, Zingler C, Schulte-Herbruggen O, Gill H, Schuff-Werner P, Virchow JC. Brain-derived neurotrophic factor in platelets and airflow limitation in asthma. Am J Respir Crit Care Med. 2005 Jan 15;171(2):115-20. doi: 10.1164/rccm.200406-758OC. Epub 2004 Oct 29.
Results Reference
background
PubMed Identifier
19237390
Citation
Lommatzsch M, Lindner Y, Edner A, Bratke K, Kuepper M, Virchow JC. Adverse effects of salmeterol in asthma: a neuronal perspective. Thorax. 2009 Sep;64(9):763-9. doi: 10.1136/thx.2008.110916. Epub 2009 Feb 22.
Results Reference
derived

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

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