Effects of Weight Loss in Obese Difficult-to-treat Asthmatics

Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01047657

Enrollment

Registered

2010-01-13

Start date

2009-11-30

Completion date

2010-12-31

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Obesity, Weight Loss

Keywords

Asthma, Obesity, weight loss

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.

Interventions

BEHAVIORALLow caloric diet plus orlistat and sibutramine

All subjetcs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Asthma control questionnaire (ACQ)	Baseline and six months

Secondary

Measure	Time frame
Inflammatory parameters	Baseline and after 6 months
Pulmonary mechanics	Baseline and after 6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026