AsthmaNCT00526344
Bronchoscopy With Bronchial Biopsies Sub-study of: Persistence of Airway Inflammation and Remodeling in Asthma Remission
An observational study of Asthma, run by Laval University at 1 site in Canada.
Trial summary
This study aims at determining the patterns of asthma remission, the prevalence of these different patterns and the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Mar 2011
- 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: Subjects with current asthma or in remission of asthma from primary care clinics will be allowed to participate to this study. Healthy subjects will also be invited by advertisements in newspapers to volunteer for this study.
Who may be able to join
- In remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (FEV1 > 90%) and normal PC20 methacholine for more than two years (with no current treatment).
- With a proven past history of asthma from medical files (reversible airway obstruction (> 12% FEV1 after bronchodilator or 20% by other means) proven by spirometry, PEF measures or methacholine challenge according to current criteria + previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
- Agree to sign the consent form.
- No other condition that could interfere with the study measurements.
Who cannot join
- Subjects using inhaled or oral anti-inflammatory agents.
- FEV1 < 1.2 L.
- Unable to adhere to the protocol requirements.
- Other current respiratory disease
- Upper or lower respiratory tract infection or use of antibiotics < 1 month.
- Use of oral corticosteroids within the last 3 months.
- Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchoscopy and Bronchial Biopsies. Sub-study of: Characteristics of Asthma Remissions
This study aims at determining the patterns of asthma remission, the prevalence of these different patterns and the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.
We therefore want to document these specificities in studying biopsies of subjects in complete remission of their asthma and those in only symptomatic remission of their asthma, in comparison with mildly symptomatic asthmatic subjects and healthy controls.
Read the detailed description
Primary Outcome Measures :
Airway inflammation and remodeling: in bronchial biopsies
Secondary Outcome Measures:
Comparisons of bronchial biopsy features between groups:
- Bronchial epithelial morphology
- Bronchial mucosa (smooth muscle, reticular basement membrane, submucosal gland,...)
- Conditions
- Asthma
- Keywords
- remission of asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| 1 | Subjects with complete remission of asthma | |
| 2 | Subjects with symptomatic remission of asthma | |
| 3 | Subjects with asthma | |
| 4 | Healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Study completionMar 2011 (estimated)
Why it stopped: No funding, study not done
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 Laval UniversityThe 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Investigators
- Louis-Philippe Boulat, MD, Principal investigator, Hôpital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526344
- Sponsor's protocol ID
- HL-07- sep-biop
- Status last verified
- Feb 2011
- First submitted
- 5 Sep 2007
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopy and Bronchial Biopsies. Sub-study of: Characteristics of Asthma Remissions
- ClinicalTrials.gov ID
- NCT00526344
- Acronym / sponsor ID
- HL-07- sep-biop
- Conditions
- Asthma
- Keywords
- remission of asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding, study not done
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Mar 2011 (estimated)
- First posted
- 10 Sep 2007 (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.
This study aims at determining the patterns of asthma remission, the prevalence of these different patterns and the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.
We therefore want to document these specificities in studying biopsies of subjects in complete remission of their asthma and those in only symptomatic remission of their asthma, in comparison with mildly symptomatic asthmatic subjects and healthy controls.
Detailed description
Primary Outcome Measures :
Airway inflammation and remodeling: in bronchial biopsies
Secondary Outcome Measures:
Comparisons of bronchial biopsy features between groups:
- Bronchial epithelial morphology
- Bronchial mucosa (smooth muscle, reticular basement membrane, submucosal gland,...)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with complete remission of asthma |
| 2 | – | –Subjects with symptomatic remission of asthma |
| 3 | – | –Subjects with asthma |
| 4 | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with current asthma or in remission of asthma from primary care clinics will be allowed to participate to this study. Healthy subjects will also be invited by advertisements in newspapers to volunteer for this study.
Key inclusion criteria (4 listed)
- In remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (FEV1 > 90%) and normal PC20 methacholine for more than two years (with no current treatment).
- With a proven past history of asthma from medical files (reversible airway obstruction (> 12% FEV1 after bronchodilator or 20% by other means) proven by spirometry, PEF measures or methacholine challenge according to current criteria + previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
- Agree to sign the consent form.
- No other condition that could interfere with the study measurements.
Key exclusion criteria (7 listed)
- Subjects using inhaled or oral anti-inflammatory agents.
- FEV1 < 1.2 L.
- Unable to adhere to the protocol requirements.
- Other current respiratory disease
- Upper or lower respiratory tract infection or use of antibiotics < 1 month.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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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.
Louis-Philippe Boulat, MD principal investigator
Hôpital Laval
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, run by Laval University at 1 site in Canada.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Feb 2011. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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 14 Feb 2011.