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

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736801
• Other study ID #: LO-1111
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: August 20, 2008
• Start date: September 2005
• Est. completion date: April 2007

Study information

• Verified date: August 2008
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• Salmeterol and Salmeterol / Fluticasone
Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.

Locations

Country	Name	City	State
Germany	University of Rostock	Rostock

Sponsors (2)

Lead Sponsor	Collaborator
University of Rostock	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lommatzsch M, Schloetcke K, Klotz J, Schuhbaeck K, Zingler D, Zingler C, Schulte-Herbrüggen 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. Epub 2004 Oct 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDNF concentrations in serum, platelets and plasma		2006 - 2007	No
Secondary	Airway hyperresponsiveness		2006 - 2007	No