AsthmaNCT00116311
Effects of Allergen Inhalation on Adenosine Receptor Expression in Sputum and Peripheral Blood
An observational study of Asthma and Healthy, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- allergen inhalation, withdrawal of medication and sputum induction
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2005to Feb 2007
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Asthmatic Subjects - Inclusion Criteria:
- Clinical diagnosis of asthma
- Steroid naive or subjects not using their inhaled steroids for the last 4 weeks, short-acting beta-agonist for rescue medication
- FEV1 > 70% of predicted
- Positive skin prick test for house dust mite, cat or grass pollen
- PC20 methacholine or histamine < 8 mg/ml
Asthmatic Subjects - Exclusion Criteria:
- Use of systemic steroids in the previous 6 weeks
- Asthma exacerbations in the previous 6 weeks
- Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago
Healthy Subjects - Inclusion Criteria:
- No airway complaints
- FEV1 > 90% of predicted
- Negative skin prick test
- PC20 methacholine or histamine > 8 mg/ml
Healthy Subjects - Exclusion Criteria:
- Use of steroids in the previous 6 weeks
- Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen, Department of Pulmonology
Groningen, 9713 GZ
About this study
Official title: Effects of Allergen Inhalation on Adenosine Receptor Expression and Mast Cell Activation in Peripheral Blood and Sputum of Asthmatics and Healthy Subjects
The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects.
We also want to study the effects of allergen inhalation on adenosine receptor expression in asthmatics. We believe that adenosine receptor expression will be upregulated after allergen inhalation.
Both hypotheses are being tested in sputum and peripheral blood.
- Being tested
- allergen inhalation, withdrawal of medication, sputum induction
- Keywords
- Adenosine receptors, asthma, sputum, peripheral blood, healthy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergen inhalationBehavioural
withdrawal of medicationBehavioural
sputum inductionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2005 (estimated)
- Study startJul 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Groningen Research Institute for Asthma and COPD
- Sponsor type
- University, hospital or other
- Investigators
- Dirkje S Postma, prof. MD PhD, Principal investigator, University Medical Center Groningen, Department of Pulmonology, hanzeplein 1, 9713 GZ Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116311
- Sponsor's protocol ID
- METc2004-253
- Status last verified
- Mar 2007
- First submitted
- 28 Jun 2005
- Last updated
- 21 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Allergen Inhalation on Adenosine Receptor Expression and Mast Cell Activation in Peripheral Blood and Sputum of Asthmatics and Healthy Subjects
- ClinicalTrials.gov ID
- NCT00116311
- Acronym / sponsor ID
- METc2004-253
- Keywords
- Adenosine receptors, asthma, sputum, peripheral blood, healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Groningen Research Institute for Asthma and COPDUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Feb 2007
- First posted
- 29 Jun 2005 (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.
The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects.
We also want to study the effects of allergen inhalation on adenosine receptor expression in asthmatics. We believe that adenosine receptor expression will be upregulated after allergen inhalation.
Both hypotheses are being tested in sputum and peripheral blood.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| allergen inhalation | Behavioural | – |
| withdrawal of medication | Behavioural | – |
| sputum induction | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2007.
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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.
Dirkje S Postma, prof. MD PhD principal investigator
University Medical Center Groningen, Department of Pulmonology, hanzeplein 1, 9713 GZ Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Healthy, run by Groningen Research Institute for Asthma and COPD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 21 Mar 2007. 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 Netherlands. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 Mar 2007.