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

NCT00736801 | Completed

• 1 other identifier: LO-1111
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Asthma

Keywords

Airway hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

• BDNF concentrations in serum, platelets and plasma

  2006 - 2007

Secondary Outcomes (1)

• Airway hyperresponsiveness

  2006 - 2007

Study Arms (1)

A

EXPERIMENTAL

Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks.

Drug: Salmeterol and Salmeterol / Fluticasone

Interventions

Salmeterol and Salmeterol / Fluticasone DRUG

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

Also known as: Serevent, Viani

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rostock: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Rostock

Rostock, 18057, Germany

Location

Related Publications (2)

• Lommatzsch M, Schloetcke K, Klotz J, Schuhbaeck K, Zingler D, Zingler C, Schulte-Herbruggen 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. doi: 10.1164/rccm.200406-758OC. Epub 2004 Oct 29.

  PMID: 15516533 BACKGROUND

• 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. doi: 10.1136/thx.2008.110916. Epub 2009 Feb 22.

  PMID: 19237390 DERIVED

MeSH Terms

Conditions

Respiratory Hypersensitivity

Interventions

Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Johann C. Virchow, MD, FCCP

  University of Rostock

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: September 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

DE (1)