|Trial name or title||A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma|
|Methods||The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.|
The target enrolment is 6200 subjects. The expected completion date for accrual and the study remains unchanged from August 2016 and February 2017 respectively.
Consent to participate in the study
Age 4-11 years old
Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation
Asthma diagnosis for at least 6 months
Ability to answer questions regarding asthma control and use a metered dose inhaler and Diskus
A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
History of at least once occurrence of asthma exacerbation within the prior 12 months
Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)
History of life-threatening asthma
Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
Subjects with only exercise-induced asthma
An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
Severe hypersensitivity to cow's milk proteins
Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Fluticasone propionate/salmeterol 100/50 twice daily
Fluticasone propionate/salmeterol 250/50 twice daily
Fluticasone propionate 100 twice daily
Fluticasone propionate 250 twice daily
Delivery Device Diskus
Time to first event in the composite endpoint of serious asthma-related outcomes (asthma-related hospitalizations, endotracheal intubations, or deaths) over the 6-month study treatment period
Time to first asthma exacerbation
|Starting date||November 2011|
|Notes||As of April 24, 2012, 313 subjects have been randomised. The target enrolment is 6200 subjects. The expected completion date for accrual and the study remains unchanged from August 2016 and February 2017 respectively.|