Last updated: 11/06/2018 23:55:33
Viapaed Study In Children And Adolescents With Asthma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Steroid-sparing management of the salmeterol/fluticasone 50/100µg b.i.d. combination compared to fluticasone 200µg b.i.d. in children and adolescents with moderate asthma
Trial description: Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change from Baseline in mean morning peak expiratory flow (PEF)
Timeframe: Baseline up to Week 8
Secondary outcomes:
Daily Asthma symptom score
Timeframe: Up to Week 8
Number of calendar days without asthma symptoms
Timeframe: Up to Week 8
Number of necessary administrations of salbutamol
Timeframe: Up to Week 8
Number of weeks with good asthma control
Timeframe: Up to Week 8
Change in forced vital capacity (FVC) in % of reference value
Timeframe: Up to Week 8
Change in forced expiratory volume in 1 second (FEV1) in % of reference value
Timeframe: Up to Week 8
Change in peak expiratory flow rate (PEFR) in % of reference value
Timeframe: Up to Week 8
Change in mean morning peak flow in % of reference value
Timeframe: Up to Week 8
Percentage of subjects with a peak flow variability of 20%
Timeframe: Up to Week 8
Number of subject withdrawals due to asthma exacerbations
Timeframe: Up to Week 8
Number of subjects with adverse events (AEs)
Timeframe: Up to Week 8
Interventions:
Enrollment:
285
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gappa M, Zachgo W, von Berg A, et al. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). Pediatr Pulmonol 2009;44(11):1132–42.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 2004 to April 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 16 years
Accepts healthy volunteers
No
- Inclusion Criteria:
- Children aged 4 to 16 years with an established history of perennial asthma.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Children aged 4 to 16 years with an established history of perennial asthma.
- Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
- 15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
- Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
- Subjects/guardians who have given written informed consent to participate in the study.
- Subjects /guardians who are able to understand and complete a diary record card (DRC).
- Subjects who are able to use a Mini-Wright Peak Flow meter.
- Sexually active female adolescents must use adequate contraception.
- Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.
Trial location(s)
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Remscheid, Nordrhein-Westfalen, Germany, 42899
Status
Terminated/Withdrawn
Showing 1 - 6 of 98 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-12-04
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
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