Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Asthma control questionnaire (ACQ)
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Difficult-to-treat asthma
- •Body mass index > 30kg/m2
Exclusion Criteria
- •Subjets older than 65 years
- •Current smoking
- •Past smoking history (> 10 pack-year)
- •Pregnancy
- •Contraindication for Orlistat or Sibutramine
Arms & Interventions
weight loss
Intervention: Low caloric diet plus orlistat and sibutramine (Behavioral)
Control
Outcomes
Primary Outcomes
Asthma control questionnaire (ACQ)
Time Frame: Baseline and six months
Secondary Outcomes
- Inflammatory parameters(Baseline and after 6 months)
- Pulmonary mechanics(Baseline and after 6 months)