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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047657
• Other study ID #: OBSTRUÇÃOHC-01
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2010
• Last updated: February 21, 2011
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Body Weight
• Obesity
• Weight Loss

Intervention

Behavioral:
• Low caloric diet plus orlistat and sibutramine
All subjetcs

Locations

Country	Name	City	State
Brazil	University of São Paulo - Heart Institute and Hospital das Clínicas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control questionnaire (ACQ)		Baseline and six months	No
Secondary	Inflammatory parameters		Baseline and after 6 months	No
Secondary	Pulmonary mechanics		Baseline and after 6 months	No