CompletedPhase 4

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

472 participantsStarted 2004-05

Plain-language 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 association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day. ADERE PROJECT (Pediatric)

Who can participate

Age range6 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The main outcome, compliance, is being measured by the number of doses used of the drug salmeterol combined with fluticasone (Seretide Diskus) divided by the number of doses foreseen for the time considered.

Timeframe: After 90 days of treatment

Trial details

NCT IDNCT01476059

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-12

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