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

NCT ID: NCT00736801

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Allergic Asthma

Keywords

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Airway hyperresponsiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

Salmeterol and Salmeterol / Fluticasone

Intervention Type DRUG

Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.

Interventions

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Salmeterol and Salmeterol / Fluticasone

Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.

Intervention Type DRUG

Other Intervention Names

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Serevent Viani

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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University of Rostock

Principal Investigators

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Johann C. Virchow, MD, FCCP

Role: STUDY_CHAIR

University of Rostock

Locations

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University of Rostock

Rostock, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15516533 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19237390 (View on PubMed)

Other Identifiers

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LO-1111

Identifier Type: -

Identifier Source: org_study_id