Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Budesonide pMDI
Product Code: Budesonide pMDI
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration unit: µg microg
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 1. 2. Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1. 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 4 weeks prior to Visit 1. 6. Has participated in a prior SYMBICORT® clinical study during the 12 months prior to Visit 1. 7. Is receiving treatment with a beta-blocker (including eye drops). 8. Has used a LABA within 30 days prior to Visit 1. 9. Has used inhaled corticosteroids in combination with other non-steroidal asthma medications (eg, leukotriene modifiers, mast cell stabilizers, 5 lipoxygenase inhibitors [5-LOIs]) within 30 days prior to Visit 1. 10. Has used omalizumab (XOLAIR®, Genentech/Novartis) or any other monoclonal or polyclonal antibody therapy 6 months prior to Visit 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Additional efficacy endpoints include the in clinic spirometry variables forced vital capacity (FVC) and forced mid expiratory flow between 25% and 75% of the forced vital capacity (FEF25 75), number of withdrawals due to predefined criteria for worsening of asthma, and the ePRO variables evening PEF, nighttime and daytime asthma symptom scores, nighttime awakenings due to asthma symptoms, and daytime and nighttime short-acting bronchodilator (reliever) medication use. | — |
Countries
Bulgaria, Hungary, Latvia, Poland, Slovakia
Outcome results
None listed