AsthmaEATANCT00567463
Early Antiinflammatory Treatment of Asthma
A study testing Fluticasone in people with Asthma and Bronchial Hyperreactivity, run by Laval University at 1 site in Canada.
Trial summary
The inflammatory process that leads to the development of asthma may be present before the onset of asthma symptoms and cause a certain degree of airway hyperresponsiveness. Without treatment it may induce irreversible airway structural changes that are associated with permanent changes in airway functions, persistent… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Bronchial Hyperreactivity
- What is being tested?
- Fluticasone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Dec 1998to Dec 2005
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women 18 to 45 years old.
- Methacholine PC20 0,5-16 mg/ml and FEV1 greater than 80% pred.
- Asymptomatic AHR patients will have had no past or present symptoms of intermittent dyspnea or wheezing, chronic cough or phlegm production as defined by negative responses to the European community respiratory health survey (ECRHS) questionnaire. They will also never have experienced symptoms similar to those induced by the methacholine challenge (misinterpretation of asthma symptoms).
- Subjects with mild intermittent symptoms will have had asthma symptoms less than twice a week in the last 3 months. They will, however, demonstrate variable airflow obstruction according to the Canadian asthma consensus criteria. They will have required asthma medication at least occasionnally within the last year.
- At least one positive response to indoor allergens (cats, dogs, housedust mites or cockroach).
- At least one first degree relative with asthma.
- Current exposure to a dog or a cat at home.
- FEV1 greater than 80% of predicted (Knudson 1983).
Who cannot join
- Subjects who have used inhaled corticosteroids or any other bronchial anti-inflammatory agents in the past.
- Subjects who smoked more than 6 packs/year, or who smoked in the last twelve months.
- Poor-perceivers of airflow obstruction (Borg score = 1 on methacholine challenge at 20% fall in FEV1).
- Women either pregnant or breastfeeding or those without adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Anti-inflammatory Treatment of Asymptomatic or Mildly Symptomatic Airway Hyperresponsiveness
- The inflammatory process that leads to the development of asthma may be present before the onset of asthma symptoms and cause a certain degree of airway hyperresponsiveness. Without treatment it may induce irreversible airway structural changes that are associated with permanent changes in airway functions, persistent airway hyperresponsiveness and lead to the development of asthma symptoms.
- Atopic subjects with asymptomatic airway hyperresponsiveness and first degree relatives with a history of asthma are at higher risk to develop symptomatic asthma. Early treatment of airway inflammation in these predisposed subjects with " borderline " or mild airway hyper-responsiveness could prevent the development of asthma symptoms, and reduce or even normalize airway responsiveness.
- In very mild asthmatic subjects (bronchodilator need < thrice a week), early anti-inflammatory treatment can lead to " normalisation " or airway responsiveness in a significant number of subjects and prevent the need for subsequent regular therapy. This is particularly true for those showing blood/sputum eosinophilia.
Objectives: To compare perception of bronchoconstriction, pulmonary function and airway inflammation in subjects with mild symptomatic asthma and asymptomatic asymptomatic airway hyperresponsiveness
Methods: To compare the influence of inhaled fluticasone propionate 250 mcg/day for 3 months followed by 100 mcg/day for 9 months on airway inflammation and methacholine responsiveness in a double-blind, placebo-controlled, parallel groups study including non-smoking atopic subjects with mild asthma and asymptomatic airway hyperresponsiveness
Read the detailed description
- Evaluate the change in airway hyperresponsiveness and in inflammatory markers in the blood and sputum in the population studied following a 3-month course of fluticasone 250 µg per day followed by a 9-month course of fluticasone 1000 µg per day (before supper) compared to placebo as measured on a regular basis over a two year period.
- This study will include:
- A baseline evaluation period of 2 weeks before starting the 3-month treatment period followed by the 9-month treatment period.
- Treatment will be double-blinded, randomized, parallel design.
- A follow-up period of one year.
Optional: Bronchoscopies with bronchial biopsy sampling will be performed before and after tratment in a subgroup of subjects to determine what is the influence of this corticosteroid treatment on airway inflammation and remodelling.
- Conditions
- Asthma, Bronchial Hyperreactivity
- Being tested
- Fluticasone
- Keywords
- Asthma, Bronchial hyperresponsiveness, Methacholine, Induced sputum, bronchial biopsies
- Medical subject headings
- Asthma, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluticasoneDevice
Fluticasone 250mcg for 3 months followed by 100mcg for 9 months, one puff once a day at supper time
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo inhalator will be used by subjects in the placebo group(same course as patients in the treated group) Receives: Device: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in airway hyperresponsiveness in the population studied following 3-month of fluticasone 250 µg per day followed by 9-month of fluticasone 1000 µg per day compared to placebo.
Measured: measurements every 3 months for 2 years
Secondary outcomes (1)
- Evaluate the change in inflammatory markers in blood and sputum vs placebo. - Determine if this treatment will reduce asthma symptoms over a period of 2 years. - Determine its influence on airway inflammation and remodelling (bronchial biopsies).
Measured: measurements every 3 months during two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 1998
- Study completionDec 2005
Why it stopped: Completed
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Hôpital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567463
- Sponsor's protocol ID
- HL-EATA-550
- Acronym
- EATA
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2007
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anti-inflammatory Treatment of Asymptomatic or Mildly Symptomatic Airway Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT00567463
- Acronym / sponsor ID
- EATA / HL-EATA-550
- Conditions
- Asthma, Bronchial Hyperreactivity
- Keywords
- Asthma, Bronchial hyperresponsiveness, Methacholine, Induced sputum, bronchial biopsies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Dec 1998
- Study completion
- Dec 2005 (actual)
- First posted
- 5 Dec 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.
- The inflammatory process that leads to the development of asthma may be present before the onset of asthma symptoms and cause a certain degree of airway hyperresponsiveness. Without treatment it may induce irreversible airway structural changes that are associated with permanent changes in airway functions, persistent airway hyperresponsiveness and lead to the development of asthma symptoms.
- Atopic subjects with asymptomatic airway hyperresponsiveness and first degree relatives with a history of asthma are at higher risk to develop symptomatic asthma. Early treatment of airway inflammation in these predisposed subjects with " borderline " or mild airway hyper-responsiveness could prevent the development of asthma symptoms, and reduce or even normalize airway responsiveness.
- In very mild asthmatic subjects (bronchodilator need < thrice a week), early anti-inflammatory treatment can lead to " normalisation " or airway responsiveness in a significant number of subjects and prevent the need for subsequent regular therapy. This is particularly true for those showing blood/sputum eosinophilia.
Objectives: To compare perception of bronchoconstriction, pulmonary function and airway inflammation in subjects with mild symptomatic asthma and asymptomatic asymptomatic airway hyperresponsiveness
Methods: To compare the influence of inhaled fluticasone propionate 250 mcg/day for 3 months followed by 100 mcg/day for 9 months on airway inflammation and methacholine responsiveness in a double-blind, placebo-controlled, parallel groups study including non-smoking atopic subjects with mild asthma and asymptomatic airway hyperresponsiveness
Detailed description
- Evaluate the change in airway hyperresponsiveness and in inflammatory markers in the blood and sputum in the population studied following a 3-month course of fluticasone 250 µg per day followed by a 9-month course of fluticasone 1000 µg per day (before supper) compared to placebo as measured on a regular basis over a two year period.
- This study will include:
- A baseline evaluation period of 2 weeks before starting the 3-month treatment period followed by the 9-month treatment period.
- Treatment will be double-blinded, randomized, parallel design.
- A follow-up period of one year.
Optional: Bronchoscopies with bronchial biopsy sampling will be performed before and after tratment in a subgroup of subjects to determine what is the influence of this corticosteroid treatment on airway inflammation and remodelling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: FluticasonePlacebo inhalator will be used by subjects in the placebo group(same course as patients in the treated group) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men or women 18 to 45 years old.
- Methacholine PC20 0,5-16 mg/ml and FEV1 greater than 80% pred.
- Asymptomatic AHR patients will have had no past or present symptoms of intermittent dyspnea or wheezing, chronic cough or phlegm production as defined by negative responses to the European community respiratory health survey (ECRHS) questionnaire. They will also never have experienced symptoms similar to those induced by the methacholine challenge (misinterpretation of asthma symptoms).
- Subjects with mild intermittent symptoms will have had asthma symptoms less than twice a week in the last 3 months. They will, however, demonstrate variable airflow obstruction according to the Canadian asthma consensus criteria. They will have required asthma medication at least occasionnally within the last year.
- At least one positive response to indoor allergens (cats, dogs, housedust mites or cockroach).
Key exclusion criteria (4 listed)
- Subjects who have used inhaled corticosteroids or any other bronchial anti-inflammatory agents in the past.
- Subjects who smoked more than 6 packs/year, or who smoked in the last twelve months.
- Poor-perceivers of airflow obstruction (Borg score = 1 on methacholine challenge at 20% fall in FEV1).
- Women either pregnant or breastfeeding or those without adequate contraception.
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 |
|---|---|---|
| FluticasoneFluticasone 250mcg for 3 months followed by 100mcg for 9 months, one puff once a day at supper time | Device | Placebo |
Primary outcome
Evaluate the change in airway hyperresponsiveness in the population studied following 3-month of fluticasone 250 µg per day followed by 9-month of fluticasone 1000 µg per day compared to placebo.
Time frame: measurements every 3 months for 2 years
1 secondary outcome
- Evaluate the change in inflammatory markers in blood and sputum vs placebo. - Determine if this treatment will reduce asthma symptoms over a period of 2 years. - Determine its influence on airway inflammation and remodelling (bronchial biopsies).
Time frame: measurements every 3 months during two years
Results and safety
The study was stopped early (reason given: Completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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 Boulet, 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?
A study testing Fluticasone in people with Asthma and Bronchial Hyperreactivity, 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Completed). 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.
What does the primary outcome measure?
Evaluate the change in airway hyperresponsiveness in the population studied following 3-month of fluticasone 250 µg per day followed by 9-month of fluticasone 1000 µg per day compared to placebo. (time frame: measurements every 3 months for 2 years). 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 11 Feb 2011.