Asthma
Conditions
Interventions
Trade Name: DISKUS
Pharmaceutical Form:
INN or Proposed INN: SALMETEROL XINAFOATE
CAS Number: 94749-08-3
Other descriptive name: SALMETEROL XINAFOATE
Concentration unit: µg microgram(s)
Concentration
Sponsors
GlaxoSmithKline Research & Development Ltd.
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 456 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The absolute and percentage change from baseline in morning pre-dose FEV1 at week 12. The change from baseline in percentage of symptom and rescue-free days over weeks 1-12. The change from baseline in mean change in evening PEFR over weeks 1-12. ;Timepoint(s) of evaluation of this end point: The change from baseline in percentage of symptom and rescue-free days over weeks 1-12. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective was to demonstrate the superior clinical effectiveness of SFC compared with montelukast in the management of persistent asthma in children aged 6-14 years.;Primary end point(s): The primary outcome was the change in the mean morning peak expiratory flow (PEFR) (L/min) over weeks 1-12 as collected on diary record cards;Timepoint(s) of evaluation of this end point: Mean over 1-12 weeks;Secondary Objective: Secondary study objectives were to assess the effect of each treatment SFC and montelukast on lung function, asthma control, Health Outcomes including the child’s q uality 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 centres where a valid translation is available. | — |
Countries
Argentina, Colombia, Costa Rica, Ecuador, Mexico, Peru, Turkey, Venezuela, Bolivarian Republic of
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed