AsthmaABHRNCT01549483
Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR)
An observational study of Asthma and Airway Hyperresponsiveness, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to study differences in small airways (<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Airway Hyperresponsiveness
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Jun 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Out-patient clinic
Who may be able to join
- Age between 18 and 65 years.
- FEV1 > 80% predicted post bronchodilator.
- PC20 methacholine >8 mg/ml.
- No history of asthma or previous use of asthma medication.
- Age between 18 and 65 years.
- FEV1 > 80% predicted.
Show all 9Show fewer
- PC20 methacholine ≤8 mg/ml.
- Doctor's diagnosis of asthma.
- No history of Chronic obstructive pulmonary disease (COPD).
Who cannot join
- Use of inhaled or oral steroids, antihistamines, nedocromil, theophylline, leukotrien antagonists or long-acting beta-agonists for at least three weeks before the start of the study.
- Any disease that may affect the outcome of the study as judged by the Investigator.
- FEV1 <1.2 liter.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness
The purpose of this study is to study differences in small airways (<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.
- Conditions
- Asthma, Airway Hyperresponsiveness
- Keywords
- asthma, airway hyperresponsiveness, asymptomatic airway hyperresponsiveness, small airways
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | asthmatic subjects | |
| Asymptomatic AHR | Asymptomatic subjects with airway hyperresponsiveness | |
| Control | Healthy controls, without airway hyperresponsiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral airway resistance measured with impulse oscillometry (IOS)
Difference between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R5-20).
Measured: visit 1
Secondary outcomes (3)
Small airway parameters
Forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75), alveolar nitric oxide (NO), residual volume (RV), RV/total lung capacity (TLC)
Measured: visit 1
mRNA expression in nasal epithelium
Measured: visit 2
Peripheral airway resistance measured during provocation test
Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine
Measured: visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionJun 2013
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.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten van den Berge, University Medical Center Groningen
- Investigators
- Maarten Van den Berge, M.D., PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549483
- Sponsor's protocol ID
- ABHR001
- Acronym
- ABHR
- Status last verified
- Jan 2015
- First submitted
- 6 Mar 2012
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT01549483
- Acronym / sponsor ID
- ABHR / ABHR001
- Conditions
- Asthma, Airway Hyperresponsiveness
- Keywords
- asthma, airway hyperresponsiveness, asymptomatic airway hyperresponsiveness, small airways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Mar 2012 (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 study differences in small airways (<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –asthmatic subjects |
| Asymptomatic AHR | – | –Asymptomatic subjects with airway hyperresponsiveness |
| Control | – | –Healthy controls, without airway hyperresponsiveness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patient clinic
Key inclusion criteria (9 listed)
- Age between 18 and 65 years.
- FEV1 > 80% predicted post bronchodilator.
- PC20 methacholine >8 mg/ml.
- No history of asthma or previous use of asthma medication.
- Age between 18 and 65 years.
Key exclusion criteria (3 listed)
- Use of inhaled or oral steroids, antihistamines, nedocromil, theophylline, leukotrien antagonists or long-acting beta-agonists for at least three weeks before the start of the study.
- Any disease that may affect the outcome of the study as judged by the Investigator.
- FEV1 <1.2 liter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral airway resistance measured with impulse oscillometry (IOS)
Time frame: visit 1
Difference between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R5-20).
3 secondary outcomes
Small airway parameters
Time frame: visit 1
mRNA expression in nasal epithelium
Time frame: visit 2
Peripheral airway resistance measured during provocation test
Time frame: visit 2
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 16 Jan 2015.
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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.
Maarten Van den Berge, M.D., PhD principal investigator
University Medical Center Groningen
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 Airway Hyperresponsiveness, run by University Medical Center Groningen 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?
The sponsor lists 9 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 16 Jan 2015. 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?
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?
Peripheral airway resistance measured with impulse oscillometry (IOS) (time frame: visit 1). It is what the study was designed to measure, not a finding.
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 16 Jan 2015.