ObesityORPANCT00532363
Obesity and Asthma:a Specific Phenotype
An observational study of Obesity and Asthma, run by Laval University at 1 site in Canada.
Trial summary
Clinicians frequently observed that obese women referred for severe asthma do not respond to treatment. These patients, despite the presence of wheezing, often have normal expiratory flows and normal or "borderline" airway responsiveness. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Sep 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from advertisements in newspapers and from the hospital primary care asthma clinic and will be offered to participate to the study.
Who may be able to join
- Will be women aged 18 years and over
- Will be in good health apart from asthma or obesity as determined by history and physical examination (No other condition that could influence the proposed tests).
- All will be non smokers or ex-smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
- Subjects will have a physician's made diagnosis of severe asthma and treated with corticosteroids.
Who cannot join
- Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
- Subjects having a co-existing illness that precludes them from the trial.
- Pregnancy or lactation
- Contraindication to the prednisone treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity-related Pseudo-asthma (ORPA): Description of a Novel Clinical Entity
Clinicians frequently observed that obese women referred for severe asthma do not respond to treatment. These patients, despite the presence of wheezing, often have normal expiratory flows and normal or "borderline" airway responsiveness.
It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for which clinical definition and characteristics and optimal management remain to be determined.
The aim of this study was to study the pulmonary physiological and airway inflammatory characteristics and response to treatment of obese women considered to have clinically severe asthma in order to demonstrate that some of these patients have a phenotype that is not that of asthma.
Read the detailed description
Twenty-five obese women (BMI over 30) and 25 non-obese women (18>BMI<25) considered to have severe asthma by their physician and requiring corticosteroids to control their asthma will have the following investigation:
- Respiratory questionnaires focussing on the nature and time-course of symptoms, asthma control criteria, medication use.
- Physical examination, including measures of BMI, waist, hips and ratio waist/hips
- Blood test for Complete Blood Count, blood glucose, total IgE levels and markers of systemic inflammation (C-Reactive Protein, fibrinogen…)
- Spirometry and bronchodilator response.
- Induced sputum analysis and Exhaled Breath Condensate pH to assess airway inflammation.
- Skin prick tests with a battery of common airborne allergens
- Measurement of lung volumes and airway resistance + MIP and MEP.
- Methacholine challenge (up to 16 mg/ml) with Borg scores for breathlessness and chest tightness.
- Medical subject headings
- Obesity, 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 |
|---|---|---|
| Obese asthmatics | Obese subjects with asthma (on inhaled corticosteroids) | |
| Non obese asthmatics | Non obese subjects with asthma (on inhaled corticosteroids) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startSep 2005
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-Philippe Boulet, Laval University
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Hôpital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532363
- Sponsor's protocol ID
- HL-ORPA-1171
- Acronym
- ORPA
- Status last verified
- Feb 2012
- First submitted
- 18 Sep 2007
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lessard A, Turcotte H, Cormier Y, Boulet LP. Obesity and asthma: a specific phenotype? Chest. 2008 Aug;134(2):317-323. doi: 10.1378/chest.07-2959. Epub 2008 Jul 18.
PubMed 18641097
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity-related Pseudo-asthma (ORPA): Description of a Novel Clinical Entity
- ClinicalTrials.gov ID
- NCT00532363
- Acronym / sponsor ID
- ORPA / HL-ORPA-1171
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Sep 2010 (actual)
- First posted
- 20 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.
Clinicians frequently observed that obese women referred for severe asthma do not respond to treatment. These patients, despite the presence of wheezing, often have normal expiratory flows and normal or "borderline" airway responsiveness.
It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for which clinical definition and characteristics and optimal management remain to be determined.
The aim of this study was to study the pulmonary physiological and airway inflammatory characteristics and response to treatment of obese women considered to have clinically severe asthma in order to demonstrate that some of these patients have a phenotype that is not that of asthma.
Detailed description
Twenty-five obese women (BMI over 30) and 25 non-obese women (18>BMI<25) considered to have severe asthma by their physician and requiring corticosteroids to control their asthma will have the following investigation:
- Respiratory questionnaires focussing on the nature and time-course of symptoms, asthma control criteria, medication use.
- Physical examination, including measures of BMI, waist, hips and ratio waist/hips
- Blood test for Complete Blood Count, blood glucose, total IgE levels and markers of systemic inflammation (C-Reactive Protein, fibrinogen…)
- Spirometry and bronchodilator response.
- Induced sputum analysis and Exhaled Breath Condensate pH to assess airway inflammation.
- Skin prick tests with a battery of common airborne allergens
- Measurement of lung volumes and airway resistance + MIP and MEP.
- Methacholine challenge (up to 16 mg/ml) with Borg scores for breathlessness and chest tightness.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese asthmatics | – | –Obese subjects with asthma (on inhaled corticosteroids) |
| Non obese asthmatics | – | –Non obese subjects with asthma (on inhaled corticosteroids) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from advertisements in newspapers and from the hospital primary care asthma clinic and will be offered to participate to the study.
Key inclusion criteria (4 listed)
- Will be women aged 18 years and over
- Will be in good health apart from asthma or obesity as determined by history and physical examination (No other condition that could influence the proposed tests).
- All will be non smokers or ex-smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
- Subjects will have a physician's made diagnosis of severe asthma and treated with corticosteroids.
Key exclusion criteria (4 listed)
- Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
- Subjects having a co-existing illness that precludes them from the trial.
- Pregnancy or lactation
- Contraindication to the prednisone treatment.
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 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 22 Feb 2012.
- Derived from this study: PubMed 18641097Lessard A, Turcotte H, Cormier Y, Boulet LP. Obesity and asthma: a specific phenotype? Chest. 2008 Aug;134(2):317-323. doi: 10.1378/chest.07-2959. Epub 2008 Jul 18.
Related trials for Obesity
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Obesity
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?
An observational study of Obesity and 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 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: finished, as of the sponsor's last update on 22 Feb 2012. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532363, which also lists 1 linked publication.
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 22 Feb 2012.