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

This study has been completed.

First Received on August 15, 2008. Last Updated on August 20, 2008 History of Changes

Sponsor:	University of Rostock
Collaborator:	GlaxoSmithKline
Information provided by:	University of Rostock
ClinicalTrials.gov Identifier:	NCT00736801

Purpose

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.

Condition	Intervention
Allergic Asthma	Drug: Salmeterol and Salmeterol / Fluticasone

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by University of Rostock:

Primary Outcome Measures:

BDNF concentrations in serum, platelets and plasma [ Time Frame: 2006 - 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Airway hyperresponsiveness [ Time Frame: 2006 - 2007 ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	September 2005
Study Completion Date:	April 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks.	Drug: Salmeterol and Salmeterol / Fluticasone Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks. Other Names: Serevent Viani

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736801

Locations

Germany
University of Rostock
Rostock, Germany, 18057

Sponsors and Collaborators

University of Rostock

GlaxoSmithKline

Investigators

Study Chair:

Johann C. Virchow, MD, FCCP

University of Rostock

More Information

Publications:

Lommatzsch M, Schloetcke K, Klotz J, Schuhbaeck K, Zingler D, Zingler C, Schulte-Herbrüggen 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. Epub 2004 Oct 29.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Feb 22.

Responsible Party:	PD Dr. med. Marek Lommatzsch, University of Rostock
ClinicalTrials.gov Identifier:	NCT00736801 History of Changes
Other Study ID Numbers:	LO-1111
Study First Received:	August 15, 2008
Last Updated:	August 20, 2008
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Rostock:

Airway hyperresponsiveness

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012