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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Fluticasone, salmeterol drug combination
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014