A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With Asthma

Study Overview
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Brief Summary
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The purpose of the study is to characterize the pharmacokinetic profiles of fluticasone propionate and/or salmeterol when delivered as a single oral inhalation dose of Fp MDPI and FS MDPI.

Official Title
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A Double-Blind (Incorporating an Open Label Comparator), 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Tolerability of Single Doses of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler Compared to ADVAIR® DISKUS® in Patients With Persistent Asthma 4 Through 11 Years of Age

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fluticasone Propionate MDPI
* Drug: Fluticasone Propionate/Salmeterol MDPI
* Drug: Fluticasone propionate/salmeterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is a male or female aged 4 through 11 years of age, inclusive Severity of disease: The patient has persistent asthma Asthma diagnosis: The patient has a diagnosis of asthma as defined by the NIH. The patient has required less than 4 inhalations per week of rescue bronchodilator (on average) for the 4 weeks preceding the SV. The patient is able to withhold (as judged by the investigator) his or her rescue medication for at least 6 hours before the SV and before all treatment visits. The patient must have a weight of 18 kg or higher. Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: The patient has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures. Female patients that have reached puberty and have a child bearing potential must have a negative serum pregnancy test at the SV. Eligible menstruating female patients unwilling to employ appropriate birth control measures to ensure pregnancy will be excluded The patient has participated as a randomized patient in any investigational drug study within 30 days (starting from the final follow-up visit of that study) preceding the SV or plans to participate in another investigational drug study at any time during this study. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug (ie, lactose). The patient has a culture-documented or suspected bacterial or viral upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI), sinus, or middle ear that has not resolved at least 2 weeks before the SV. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV. The patient has used immunosuppressive medications within 4 weeks before the SV. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. Note: Azole antifungals are prohibited. The patient is an immediate relative of an employee of the investigational center. Patients who have donated whole blood 60 days before the first dose, or receive or donate plasma, white blood cells, or platelets within the 14 days before the first dose or study drug, and for 90 days after last dose of study drug. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study. Additional criteria apply, please contact the investigator for more information.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: Fp MDPI<br>Single inhalation dose of Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA) | Drug: Fluticasone Propionate MDPI<br> <br> * Other names: Fp MDPI;Drug: Fluticasone Propionate/Salmeterol MDPI<br> <br> * Other names: FS MDPI;Drug: Fluticasone propionate/salmeterol<br> <br> * Other names: DISKUS;|
| Experimental: Treatment B: FS MDPI<br>Single inhalation dose of Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA) | Drug: Fluticasone Propionate MDPI<br> <br> * Other names: Fp MDPI;Drug: Fluticasone Propionate/Salmeterol MDPI<br> <br> * Other names: FS MDPI;Drug: Fluticasone propionate/salmeterol<br> <br> * Other names: DISKUS;|
| Active Comparator: Treatment C: Comparator<br>Single inhalation dose of fluticasone propionate/salmeterol (ADVAIR DISKUS) on Day 1 into 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, BAC, or CBA) | Drug: Fluticasone Propionate MDPI<br> <br> * Other names: Fp MDPI;Drug: Fluticasone Propionate/Salmeterol MDPI<br> <br> * Other names: FS MDPI;Drug: Fluticasone propionate/salmeterol<br> <br> * Other names: DISKUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma drug concentration (Cmax) |  | 4 months | 
| Area under the plasma drug concentration-time curve (AUCO-t) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to maximum observed plasma drug concentration (tmax) |  | 4 months |