EUCTR2010-018315-15-HUActive, not recruitingNot Applicable
A Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 µg bid with placebo, a 6-week efficacy and safety study in children aged 6 to <12 years with asthma
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 290
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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