ClinicalTrials.Veeva

Menu

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

U

University of Sao Paulo General Hospital

Status and phase

Completed
Phase 3

Conditions

Weight Loss
Asthma
Obesity

Treatments

Behavioral: Low caloric diet plus orlistat and sibutramine

Study type

Interventional

Funder types

Other

Identifiers

NCT01047657
OBSTRUÇÃOHC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups

weight loss
Experimental group
Treatment:
Behavioral: Low caloric diet plus orlistat and sibutramine
Control
No Intervention group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems