Last updated: 11/04/2018 11:07:10
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Randomised, double-blind, double-dummy, parallel-group, comparative study of salmeterol/FP 50/100mcg bd inhalation powder via Diskus with oral Montelukast (5mg QD) chewable tablets in Children 6-14 years
Trial description: This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child’s quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver’s quality of life as measured by Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: montelukast (5mg QD)
Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
Enrollment:
526
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Maspero J, Frances Guerra F, Cuevas F et al. Clin Ther 2008 ; 30(4): 1-13
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
October 2005 to April 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 14 years
Accepts healthy volunteers
No
- Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
- Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
- Hospital admission for asthma within 3 months prior to Visit 1.
- Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
- Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
- More than or 12% FEV1 reversibility following inhalation of salbutamol.
- Must also be symptomatic on short-acting beta-agonists.
- Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.
Exclusion criteria:
- Hospital admission for asthma within 3 months prior to Visit 1.
- Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
- Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.
Trial location(s)
Location
GSK Investigational Site
Capital Federal-Buenos Aires, Argentina, C1424BSF
Status
Will Be Recruiting
Location
GSK Investigational Site
Santa Fe, Santa Fe, Argentina, 3000
Status
Will Be Recruiting
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Will Be Recruiting
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-30-04
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
Additional information
Not applicable
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