A study of efficacy and safety of Budesonide pMDI 160 µg compared to Placebo in children aged 6 to < 12 years with asthma for 6 weeks twice a day

Conditions: Asthma
MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2010-018315-15-HU

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 290

Inclusion Criteria

1.Provision of signed and dated informed consent prior to conducting any study specific procedures.
2.Is between the ages of 6 and <12 years (not having reached his/her 12th birthday at the time of Visit 2).
3.Has a documented clinical diagnosis of asthma as defined by ATS (ie, a disease characterized by increased responsiveness of the trachea and bronchi to various stimuli and manifested by widespread narrowing of the airway that changes in severity either spontaneously or as a result of therapy”) for at least 6 months prior to Visit 2 that has required daily ICS therapy in the low dose range or daily therapy
with a leukotriene receptor antagonist (LTRA) as monotherapy for at least 30 days prior to Visit 2.
4.Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled SABA of greater than or equal to 70% and less than or equal to 95% of predicted normal. Polgar predicted normal standards will be used for all patients.
5.Demonstrated reversibility of FEV1 of =12% from pre-albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol. (Albuterol pMDI, 90 µg per inhalation, 4 actuations, with or without a spacer, or up to 2.5 mg of nebulized albuterol/salbutamol), A documented history of reversibility of FEV1 =12% after inhalation of a short acting ß2-agonist within 12 months prior to Visit 2 is acceptable. If the patient does not have documented historical reversibility, reversibility testing must be done at Visit 2. A maximum of 2 attempts at reversibility will be allowed: if the patient fails to demonstrate reversibility of FEV1 of =12% at Visit 2 and fulfills all other inclusion/exclusion criteria, the patient may return for repeat reversibility testing between 5-14 days after Visit 2 (see Section 3.1.2). No other Visit 2 procedures will need to be performed at the repeat reversibility testing visit. Until the retesting visit, patients must remain on their maintenance ICS or LTRA dose and avoid any excluded medications. If the patient does NOT meet reversibility criterion on repeat testing, he/she will be considered a screen failure. No additional rescreen for reversibility will be allowed.
6.Has required and received treatment with a consistent daily dose of ICS or leukotriene antagonist within the corresponding dosage range listed below for at
least 30 days prior to Visit 2:
?Beclomethasone dipropionate hydrofluoroalkane (HFA) pMDI: 80-160 µg/day
?Beclomethasone dry powder inhaler (DPI): 200-500 µg/day
?Budesonide DPI: 180-400 µg/day
?Budesonide (nebulized): 500 µg/day
?Flunisolide: 500-750 µg/day
?Flunisolide HFA: 160 µg/day
?Fluticasone HFA pMDI: 88-176 µg/day
?Fluticasone DPI: 100-200 µg/day
?Triamcinolone acetonide: 300-600 µg/day
?Ciclesonide: 80-160 µg/day
?Mometasone: 110 µg/day (US); 100 µg/day (non-US)
Montelukast: 5 mg once daily
Zafirlukast: 10 mg twice daily (approved only for children 7 years and older)
Note: Non-steroidal asthma controller medications (eg, leukotriene modifiers, mast cell stabilizers, LABAs, xanthines) should not have been used in combination with any of the above for treatment of asthma for 30 days prior to Visit 2. Patients
should not have required combination controller asthma therapy for 30 days prior to Visit 2.
7.If receiving immunotherapy, shots must have been on a stable maintenance regimen for at least 6 weeks prior to Visit 2 and was expected to rem

Exclusion Criteria

1.Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma related condition during the 6 months prior to Visit 2.
2.Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within 60 days prior to Visit 2.
3.Has any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient’s ability to participate in the study.
4.Has a known or suspected hypersensitivity to albuterol/salbutamol or budesonide and/or their excipients.
5.Has participated in another investigational drug study during the 30 days prior to Visit 2.
6.Has participated in a prior SYMBICORT® clinical study during the 12 months prior to Visit 2.
7.Is receiving treatment with a beta-blocker (including eye drops).
8.Has used a LABA within 30 days prior to Visit 2.
9.Has used inhaled corticosteroids in combination with other non-steroidal asthma controller medications (eg, leukotriene modifiers, mast cell stabilizers, 5 lipoxygenase inhibitors [5-LOIs]) within 30 days prior to Visit 2.
10.Has used omalizumab (XOLAIR®, Genentech/Novartis) or any other monoclonal or polyclonal antibody therapy 6 months prior to Visit 2.
11.Has any clinically relevant abnormal findings in physical examination or vital signs at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
12.Has a planned hospitalization at any time during the study.
13.Positive pregnancy test at any time during study.

Patients who were classified as screen failures prior to the implementation of protocol amendment 4 for not meeting exclusion criteria may be rescreened one time for study
inclusion. However, if a patient was rescreened under protocol amendment 3 and was a rescreening failure, he/she is NOT eligible to be rescreened again under amendment 4.
Note: Patients who entered run-in and did not meet randomization criteria prior to the implementation of protocol amendment 4 are NOT eligible to be rescreened.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine the efficacy of budesonide pressurized metered dose inhaler (pMDI) 160 µg twice a day (80 µg x 2 inhalations twice a day) as a single ingredient product over a 6-week period in children aged 6 to <12 years who demonstrate the need for inhaled glucocorticosteroid (ICS) controller therapy. ;Secondary Objective: The key secondary objective of this study is to determine the efficacy of budesonide pMDI 160 µg twice a day (80 µg x 2 inhalations twice a day) as a single ingredient product over a 6 week period in children aged 6 to <12 years who demonstrate the need for inhaled glucocorticosteroid (ICS) controller therapy by evaluating in clinic morning pre-dose forced expiratory volume in 1 second (FEV1).;Primary end point(s): The primary efficacy variable will be morning peak expiratory flow (PEF), collected in a daily diary via electronic patient reported outcome (ePRO).<br><br>;Timepoint(s) of evaluation of this end point: Daily

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary efficacy variable will be in-clinic morning FEV1. Other secondary efficacy variables include FVC, FEF 25-75, evening PEF, nighttime and daytime asthma symptom scores, nighttime awakenings due to asthma symptoms, and daytime and nighttime reliever medication use. Morning and evening eFEV1 will be exploratory variables.;Timepoint(s) of evaluation of this end point: In-clinic morning FEV1 will be measured at Visits 2-9 (pre-dose morning clinic FEV1, measured at least 6 hours after the last dose of inhaled SABA within a range of 70% to 95% of predicted normal).

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