Allergic AsthmaNCT00736801
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma
A study testing Salmeterol and Salmeterol / Fluticasone in people with Allergic Asthma, run by University of Rostock at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Salmeterol and Salmeterol / Fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Salmeterol and Salmeterol / Fluticasone
- Keywords
- Airway hyperresponsiveness
- Medical subject headings
- Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol and Salmeterol / FluticasoneDrug
Also called Serevent, Viani
Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks. Receives: Drug: Salmeterol and Salmeterol / Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF concentrations in serum, platelets and plasma
Measured: 2006 - 2007
Secondary outcomes (1)
Airway hyperresponsiveness
Measured: 2006 - 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startSep 2005
- Primary completionJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Johann C. Virchow, MD, FCCP, Study chair, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736801
- Sponsor's protocol ID
- LO-1111
- Status last verified
- Aug 2008
- First submitted
- 15 Aug 2008
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15516533Lommatzsch 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.
PubMed 19237390
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma
- ClinicalTrials.gov ID
- NCT00736801
- Acronym / sponsor ID
- LO-1111
- Conditions
- Allergic Asthma
- Keywords
- Airway hyperresponsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Salmeterol and Salmeterol / FluticasoneTreatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmeterol and Salmeterol / FluticasoneAlso: Serevent, VianiPatients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks. | Drug | A |
Primary outcome
BDNF concentrations in serum, platelets and plasma
Time frame: 2006 - 2007
1 secondary outcome
Airway hyperresponsiveness
Time frame: 2006 - 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
- Background: PubMed 15516533Lommatzsch 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.
- Derived from this study: PubMed 19237390Lommatzsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann C. Virchow, MD, FCCP study chair
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmeterol and Salmeterol / Fluticasone in people with Allergic Asthma, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF concentrations in serum, platelets and plasma (time frame: 2006 - 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736801, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.