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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT00736801
First received: August 15, 2008
Last updated: August 20, 2008
Last verified: August 2008
History of Changes
  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
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:

Additional 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
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 May 23, 2013