Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
|Asthma Obesity Weight Loss||Behavioral: Low caloric diet plus orlistat and sibutramine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study|
- Asthma control questionnaire (ACQ) [ Time Frame: Baseline and six months ]
- Inflammatory parameters [ Time Frame: Baseline and after 6 months ]
- Pulmonary mechanics [ Time Frame: Baseline and after 6 months ]
|Study Start Date:||November 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: weight loss||
Behavioral: Low caloric diet plus orlistat and sibutramine
|No Intervention: Control|
Study design: interventional, open label, randomized
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047657
|University of São Paulo - Heart Institute and Hospital das Clínicas|
|São Paulo, Brazil, 05403-904|
|Principal Investigator:||Sérvulo A. Dias-Júnior, MD||Heart Institute - University of São Paulo|
|Study Director:||Alberto Cukier, PhD||Heart Institute - University of São Paulo|