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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01047657
First received: January 12, 2010
Last updated: February 21, 2011
Last verified: December 2009
  Purpose

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 Intervention Phase
Asthma
Obesity
Weight Loss
Behavioral: Low caloric diet plus orlistat and sibutramine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Weight Loss in Obese Difficult-to-treat Asthmatics: a Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Asthma control questionnaire (ACQ) [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory parameters [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]
  • Pulmonary mechanics [ Time Frame: Baseline and after 6 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weight loss Behavioral: Low caloric diet plus orlistat and sibutramine
All subjetcs
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alberto Cukier, University of São Paulo
ClinicalTrials.gov Identifier: NCT01047657     History of Changes
Other Study ID Numbers: OBSTRUÇÃOHC-01
Study First Received: January 12, 2010
Last Updated: February 21, 2011
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Asthma
Obesity
Weight Loss
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Sibutramine
Orlistat
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014