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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01047657
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : February 23, 2011
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Asthma Obesity Weight Loss Behavioral: Low caloric diet plus orlistat and sibutramine Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study
Study Start Date : November 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Asthma control questionnaire (ACQ) [ Time Frame: Baseline and six months ]

Secondary Outcome Measures :
  1. Inflammatory parameters [ Time Frame: Baseline and after 6 months ]
  2. Pulmonary mechanics [ Time Frame: Baseline and after 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047657


Locations
Brazil
University of São Paulo - Heart Institute and Hospital das Clínicas
São Paulo, Brazil, 05403-904
Sponsors and Collaborators
University of Sao Paulo General Hospital
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
More Information

Responsible Party: Alberto Cukier, University of São Paulo
ClinicalTrials.gov Identifier: NCT01047657     History of Changes
Other Study ID Numbers: OBSTRUÇÃOHC-01
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: December 2009

Keywords provided by University of Sao Paulo General Hospital:
Asthma
Obesity
weight loss

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes
Orlistat
Sibutramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants