AsthmaPhase 3NCT01047657
Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
A Phase 3 study testing Low caloric diet plus orlistat and sibutramine in people with Asthma and Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are obese. The impact of weight reduction in this subpopulation of asthmatics has not been studied. Our aim is to evaluate the impact of weight reduction on asthma control of these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Obesity, Weight Loss
- What is being tested?
- Low caloric diet plus orlistat and sibutramine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Difficult-to-treat asthma
- Body mass index > 30kg/m2
Who cannot join
- Subjets older than 65 years
- Current smoking
- Past smoking history (> 10 pack-year)
- Pregnancy
- Contraindication for Orlistat or Sibutramine
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - Heart Institute and Hospital das Clínicas
São Paulo, São Paulo, 05403-904
About this study
Official title: Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are obese. The impact of weight reduction in this subpopulation of asthmatics has not been studied. Our aim is to evaluate the impact of weight reduction on asthma control of these patients.
Read the detailed description
Study design: interventional, open label, randomized
Patients selection
Thirty-three difficult to control obese asthmatic patients, aged between 18 to 65 years old will be recruited from the outpatient clinics of the Pulmonary Division of the University of Sao Paulo Hospital.
Difficult to control asthma will be defined as patients who do not achieve asthma control (according to GINA) despite best treatment regimen and checked adherence after at least three months of treatment.
Intervention: Patients will be divided in two groups: asthma treatment plus weight loss program or asthma treatment alone for 6 months without drug dose changing.
Procedures (baseline and after 6 months) - quality of life questionnaire, asthma control questionnaire, lung function tests, serum and sputum inflammatory markers.
- Conditions
- Asthma, Obesity, Weight Loss
- Being tested
- Low caloric diet plus orlistat and sibutramine
- Keywords
- Asthma, Obesity, weight loss
- Medical subject headings
- Asthma, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low caloric diet plus orlistat and sibutramineBehavioural
All subjetcs
| Study group | Role | What they receive |
|---|---|---|
| weight loss | Experimental | Not described Receives: Behavioral: Low caloric diet plus orlistat and sibutramine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control questionnaire (ACQ)
Measured: Baseline and six months
Secondary outcomes (2)
Inflammatory parameters
Measured: Baseline and after 6 months
Pulmonary mechanics
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
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 of Sao Paulo General HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Sérvulo A. Dias-Júnior, MD, Principal investigator, University of Sao PauloAlberto Cukier, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047657
- Sponsor's protocol ID
- OBSTRUÇÃOHC-01
- Status last verified
- Dec 2009
- First submitted
- 12 Jan 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
- ClinicalTrials.gov ID
- NCT01047657
- Acronym / sponsor ID
- OBSTRUÇÃOHC-01
- Conditions
- Asthma, Obesity, Weight Loss
- Keywords
- Asthma, Obesity, weight loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jan 2010 (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.
Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are obese. The impact of weight reduction in this subpopulation of asthmatics has not been studied. Our aim is to evaluate the impact of weight reduction on asthma control of these patients.
Detailed description
Study design: interventional, open label, randomized
Patients selection
Thirty-three difficult to control obese asthmatic patients, aged between 18 to 65 years old will be recruited from the outpatient clinics of the Pulmonary Division of the University of Sao Paulo Hospital.
Difficult to control asthma will be defined as patients who do not achieve asthma control (according to GINA) despite best treatment regimen and checked adherence after at least three months of treatment.
Intervention: Patients will be divided in two groups: asthma treatment plus weight loss program or asthma treatment alone for 6 months without drug dose changing.
Procedures (baseline and after 6 months) - quality of life questionnaire, asthma control questionnaire, lung function tests, serum and sputum inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight loss | Experimental | Behavioral: Low caloric diet plus orlistat and sibutramine |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Difficult-to-treat asthma
- Body mass index > 30kg/m2
Key exclusion criteria (5 listed)
- Subjets older than 65 years
- Current smoking
- Past smoking history (> 10 pack-year)
- Pregnancy
- Contraindication for Orlistat or Sibutramine
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 |
|---|---|---|
| Low caloric diet plus orlistat and sibutramineAll subjetcs | Behavioural | weight loss |
Primary outcome
Asthma control questionnaire (ACQ)
Time frame: Baseline and six months
2 secondary outcomes
Inflammatory parameters
Time frame: Baseline and after 6 months
Pulmonary mechanics
Time frame: Baseline and after 6 months
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 23 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.
Sérvulo A. Dias-Júnior, MD principal investigator
University of Sao Paulo
Alberto Cukier, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low caloric diet plus orlistat and sibutramine in people with Asthma and Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 5 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 23 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Asthma control questionnaire (ACQ) (time frame: Baseline and six months). 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 23 Feb 2011.