Status:

COMPLETED

Pediatric Study to Evaluate Treatment of Persistent Moderate or Severe Asthma With the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose - ADERE PROJECT

Lead Sponsor:

GlaxoSmithKline

Conditions:

Asthma

Eligibility:

All Genders

6-14 years

Phase:

PHASE4

Brief Summary

Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the associati...

Detailed Description

Objectives General: To evaluate the compliance degree to the treatment of asthmatic children, according to the attention received. Specific: 1. To study asthmatic compliance to the treatment propo...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Signature of a informed consent form
  • Age between 6 and 14 years old
  • Diagnosis of persistent moderate or severe asthma, according to III Brazilian Consensus on Asthma Management.
  • Home telephone available
  • Exclusion criteria:
  • Co-morbidities that may interfere with the study evaluation or that require continuous drugs, e.g., cardiopathy, gastro-esophageal reflux or diabetes.
  • Continuous systemic corticosteroid use for more than seven days
  • The patient has been treated or is being treated with allergen-specific immunetherapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2004

    Estimated Enrollment :

    472 Patients enrolled

    Trial Details

    Trial ID

    NCT01476059

    Start Date

    May 1 2004

    End Date

    December 1 2004

    Last Update

    June 27 2017

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