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OpenTrials
Completed

NCT Number: NCT01047657

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

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.

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Key information

Conditions

Asthma Body Weight Body Weight Changes Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of São Paulo - Heart Institute and Hospital das Clínicas

São Paulo, 05403-904, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low caloric diet plus orlistat and sibutramine

Behavioral

All subjetcs

Primary outcomes

  1. Asthma control questionnaire (ACQ)

    Time frame: Baseline and six months

Secondary outcomes

  1. Inflammatory parameters

    Time frame: Baseline and after 6 months

  2. Pulmonary mechanics

    Time frame: Baseline and after 6 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2010
Registry last updated
Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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