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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736801
First Posted: August 18, 2008
Last Update Posted: August 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
University of Rostock
  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: None (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:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • BDNF concentrations in serum, platelets and plasma [ Time Frame: 2006 - 2007 ]

Secondary Outcome Measures:
  • Airway hyperresponsiveness [ Time Frame: 2006 - 2007 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. med. Marek Lommatzsch, University of Rostock
ClinicalTrials.gov Identifier: NCT00736801     History of Changes
Other Study ID Numbers: LO-1111
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: August 21, 2008
Last Verified: August 2008

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
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action