NCT01047657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 23, 2011

Status Verified

December 1, 2009

Enrollment Period

1.1 years

First QC Date

January 12, 2010

Last Update Submit

February 21, 2011

Conditions

AsthmaObesityWeight Loss

Keywords

AsthmaObesityweight loss

Outcome Measures

Primary Outcomes (1)

  • Asthma control questionnaire (ACQ)

    Baseline and six months

Secondary Outcomes (2)

  • Inflammatory parameters

    Baseline and after 6 months

  • Pulmonary mechanics

    Baseline and after 6 months

Study Arms (2)

weight loss

EXPERIMENTAL
Behavioral: Low caloric diet plus orlistat and sibutramine

Control

NO INTERVENTION

Interventions

Low caloric diet plus orlistat and sibutramineBEHAVIORAL

All subjetcs

weight loss

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Difficult-to-treat asthma
  • Body mass index \> 30kg/m2

You may not qualify if:

  • Subjets older than 65 years
  • Current smoking
  • Past smoking history (\> 10 pack-year)
  • Pregnancy
  • Contraindication for Orlistat or Sibutramine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo - Heart Institute and Hospital das Clínicas

São Paulo, São Paulo, 05403-904, Brazil

Location

MeSH Terms

Conditions

AsthmaObesityWeight Loss

Interventions

Caloric RestrictionOrlistatsibutramine

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaLactonesOrganic Chemicals

Study Officials

  • Sérvulo A. Dias-Júnior, MD

    Heart Institute, University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Alberto Cukier, PhD

    Heart Institute, University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 23, 2011

Record last verified: 2009-12

Locations

BR(1)