A 12-Week study to find out if Fluticasone Propionate or Fluticasone/Salmeterol are safe and effective to treat children from 4 to 11 Years old with asthma.

Phase 1

Conditions: Persistent asthma
MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-003835-39-HU

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 841

Inclusion Criteria

a. The patient is a male or female patient 4 through 11 years of age, inclusive, when informed consent/assent (as applicable) is signed.
b. Written informed consent must be signed and dated by parent/legal guardian and the written informed assent form must be signed and dated by the patient (as applicable, per local regulations) before any study-related procedures are conducted.
c. The patient has a diagnosis of asthma as defined by the NIH. The asthma diagnosis has been present for a minimum of 3 months before SV.
d. The patient has persistent asthma with a FEV1 =50% and =90% of the value predicted for age, height, sex, and race at the SV as measured by handheld device.
e. The patient’s persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Patients who are currently on SABA regimen only or PRN only are not eligible for the study.
f. The patient has demonstrated =10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol HFA MDI (90 mcg ex-actuator) or equivalent at SV as measured by handheld device. Patients who demonstrated <10% response to a bronchodilator may retest within 7 days of their initial SV.
Patients who demonstrate response to a bronchodilator =10% and <14.50% may enter the run-in period (provided that they meet the other inclusion and none of the exclusion criteria) and may present for repeat lung function assessments by handheld device and another bronchodilator test within 14±2 days, during which they must demonstrate at least a 15% response to a bronchodilator. If the criteria are not met, patients may continue in the run-in period for up to 14 additional days to meet the lung function assessment and response to bronchodilator criteria (1 final attempt) for randomization. Patients may only continue in the run-in period if the investigator determines, by assessing the patient’s asthma status (at each investigational center visit), that it is safe for the patient to continue.
g. The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device. Patients who fail to demonstrate technically acceptable lung function assessments may retest within 7 days of their initial SV.
h. The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to use an MDI device and an MDPI device.
i. The patient is able to withhold (as judged by the investigator) his/her rescue medication for at least 6 hours before SV and all TVs where lung function assessments are performed.
j. The patient is assessed as otherwise healthy, with clinically acceptable medical history, physical examination, and vital signs within acceptable ranges for children with asthma as assessed by the investigator.
k. All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol at the SV for use as needed for the duration of the study.
l. Female patients who have reached puberty and achieved menarche (as determined by the investigator) must be counseled regarding the possible unknown risks associated with IMP during pregnancy following permission of the

Exclusion Criteria

a. The patient has a history of life-threatening asthma exacerbation (asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures).
b. The patient is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the patient’s last study-related visit.
c. The patient has participated as a randomized patient in any investigational drug study within the 30 days or within 5 half-lives preceding the SV (or prescreening visit) or plans to participate in another investigational drug study at any time during this study.
d. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the IMP or rescue medication formulation. Dietary lactose intolerance does not exclude from inclusion or as per the investigator’s medical discretion.
e. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
f. The patient has been treated with any of the prohibited medications during the prescribed washout periods before the SV.
g. The patient currently smokes or has a smoking history. The patient must not have used tobacco products within the past year.
h. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV (note: patients who develop a URI or LRI during the run-in period may be rescreened 2 weeks after symptoms resolve).
i. 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.
j. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients who initiated immunotherapy 90 days or more before the SV and have been on a stable (maintenance) dose for 30 days or more before the SV may be considered for inclusion.
k. The patient has used immunosuppressive medications within 30 days before the SV.
l. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications.
m. 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 run-in period.
n. The patient has a history of a positive test for HIV, active hepatitis B virus, or hepatitis C infection.
o. The patient is an immediate relative of an employee of the clinical investigational center.
p. A member of the patient’s household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
q. The patient has a disease/condition that, in the medical judgment of the investigator, would put the safety of the patient at risk or that could affect the efficacy or safety analysis if the disease/con

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method