- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00736801
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma
August 20, 2008 updated by: University of Rostock
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rostock, Germany, 18057
- University of Rostock
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks.
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Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BDNF concentrations in serum, platelets and plasma
Time Frame: 2006 - 2007
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2006 - 2007
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Airway hyperresponsiveness
Time Frame: 2006 - 2007
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2006 - 2007
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Johann C. Virchow, MD, FCCP, University of Rostock
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
August 15, 2008
First Submitted That Met QC Criteria
August 15, 2008
First Posted (Estimate)
August 18, 2008
Study Record Updates
Last Update Posted (Estimate)
August 21, 2008
Last Update Submitted That Met QC Criteria
August 20, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Salmeterol Xinafoate
Other Study ID Numbers
- LO-1111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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