Last updated: 11/03/2018 14:44:58
Pediatric study to evaluate treatment of persistent moderate or severe asthma with the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose - ADERE PROJECTADERE (Ped)
GSK study ID
113244
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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
Secondary outcomes:
Disease control, evaluated by information in the questionnaires.
Timeframe: After 90 days of treatment
Regular medical attention sought, evaluated by information in the questionnaires
Timeframe: After 90 days of treatment
Additional resources in the event of attacks
Timeframe: After 90 days of treatment
Improvement in the quality of life.
Timeframe: After 90 days of treatment
Increase in the weekly number of nocturnal awakening or the number of awakenings per night
Timeframe: After 90 days of treatment
Increase in the use of rescue drug
Timeframe: After 90 days of treatment
Interventions:
Other: Telephone follow-up
Other: No telephone follow-up
Enrollment:
472
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, salmeterol
Collaborators
GSK
Study date(s)
May 2004 to December 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 14 years
Accepts healthy volunteers
No
- Signature of a informed consent form
- Age between 6 and 14 years old
- 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
Inclusion and exclusion criteria
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
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-10-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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