6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
Condition: Asthma
MeSH terms: Asthma
Intervention: ADVAIR 100/50mcg; ADVAIR 250/50mcg; FLOVENT 100mcg; FLOVENT 250mcg
Intervention description: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months; fluticasone propionate (100) twice daily (AM and PM) for 6 months; fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Intervention MeSH terms: Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6250.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: pediatric; ADVAIR; FLOVENT; asthma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Consent to participate in the study

          2. Age 4-11 years old

          3. 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

          4. Asthma diagnosis for at least 6 months

          5. Ability to answer questions regarding asthma control and use a metered dose inhaler
             and DISKUS

          6. 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.

          7. History of at least once occurrence of asthma exacerbation within the prior 12 months

          8. 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)

        Exclusion Criteria:

          1. History of life-threatening asthma

          2. Unstable asthma

          3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms

          4. 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.

          5. Respiratory infection

          6. Subjects with only exercise-induced asthma

          7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations
             in the last 12 months

          8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the
             last 12 months

          9. Other current evidence of clinically significant uncontrolled disease/conditions of
             any body or organ system

         10. 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

         11. Participation in an interventional study or used any investigational drug for any
             disease state within the last 30 days

         12. 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

         13. Severe hypersensitivity to cow's milk proteins

         14. 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

         15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g.,
             ritonavir, ketoconazole, itraconzole)

         16. Affiliation with investigator's site, including a immediate family member of the
             participating investigator, sub-investigator, study coordinator, or employee of the
             participating investigator.

         17. 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.