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

February 21, 2011 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-904
        • University of São Paulo - Heart Institute and Hospital das Clínicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: weight loss
Behavioral: Low caloric diet plus orlistat and sibutramine
All subjetcs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma control questionnaire (ACQ)
Time Frame: Baseline and six months
Baseline and six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory parameters
Time Frame: Baseline and after 6 months
Baseline and after 6 months
Pulmonary mechanics
Time Frame: Baseline and after 6 months
Baseline and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Sérvulo A. Dias-Júnior, MD, Heart Institute, University of São Paulo
  • Study Director: Alberto Cukier, PhD, Heart Institute, University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 21, 2011

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBSTRUÇÃOHC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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