Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
Primary Purpose
Asthma, Obesity, Weight Loss
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Low caloric diet plus orlistat and sibutramine
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Obesity, weight loss
Eligibility Criteria
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
Sites / Locations
- University of São Paulo - Heart Institute and Hospital das Clínicas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
weight loss
Control
Arm Description
Outcomes
Primary Outcome Measures
Asthma control questionnaire (ACQ)
Secondary Outcome Measures
Inflammatory parameters
Pulmonary mechanics
Full Information
NCT ID
NCT01047657
First Posted
January 12, 2010
Last Updated
February 21, 2011
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01047657
Brief Title
Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
Official Title
Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Procedures (baseline and after 6 months) - quality of life questionnaire, asthma control questionnaire, lung function tests, serum and sputum inflammatory markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity, Weight Loss
Keywords
Asthma, Obesity, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weight loss
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Low caloric diet plus orlistat and sibutramine
Intervention Description
All subjetcs
Primary Outcome Measure Information:
Title
Asthma control questionnaire (ACQ)
Time Frame
Baseline and six months
Secondary Outcome Measure Information:
Title
Inflammatory parameters
Time Frame
Baseline and after 6 months
Title
Pulmonary mechanics
Time Frame
Baseline and after 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sérvulo A. Dias-Júnior, MD
Organizational Affiliation
Heart Institute, University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Cukier, PhD
Organizational Affiliation
Heart Institute, University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo - Heart Institute and Hospital das Clínicas
City
São Paulo
ZIP/Postal Code
05403-904
Country
Brazil
12. IPD Sharing Statement
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Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
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