Resumen

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.

Descripción detallada

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.

Elegibilidad

Edad mínima: 4 YearsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

History of life-threatening asthma
Unstable 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.
Respiratory infection
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.

Intervenciones

drug

ADVAIR 100/50mcg

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

drug

ADVAIR 250/50mcg

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

drug

FLOVENT 100mcg

fluticasone propionate (100) twice daily (AM and PM) for 6 months

drug

FLOVENT 250mcg

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Ubicaciones

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Nueve de Julio, Buenos Aires, Argentina

GSK Investigational Site

Concepción del Uruguay, Entre Ríos Province, Argentina

GSK Investigational Site

Paraná, Entre Ríos Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Lanús, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

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

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

ADVAIR 100/50mcg

ADVAIR 250/50mcg

FLOVENT 100mcg

FLOVENT 250mcg

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores