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Completed

NCT Number: NCT00736801

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

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.

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Key information

Conditions

Allergic Asthma Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rostock

Rostock, 18057, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salmeterol and Salmeterol / Fluticasone

Drug

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

Other names: Serevent, Viani

Primary outcomes

  1. BDNF concentrations in serum, platelets and plasma

    Time frame: 2006 - 2007

Secondary outcomes

  1. Airway hyperresponsiveness

    Time frame: 2006 - 2007

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 18, 2008
Registry last updated
Aug 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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