Asthma MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Symbicort pMDI 80/2.25
Product Code: Symbicort pMDI 80/2.25
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration u
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent prior to conducting any studyspecific procedures. 2. Is between the ages of 6 and <12 years (not having reached his/her 12th birthday at the time of Visit 1). 3. Has a documented clinical diagnosis of asthma as defined by the American Thoracic Society (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 1. 4. Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting ß2-agonist (SABA) and at least 48 hours after the last dose of inhaled LABA of =60% and =85% of predicted normal. Polgar predicted normal standards will be used for all patients. If the patient is taking a fixed combination of ICS and LABA, the patient is to be placed on a comparable dose of ICS without the addition of a LABA at least 48 hours prior to spirometry testing. 5. Demonstrated reversibility of FEV1 of =15% from pre-albuterol level within 15 to 30 minutes after administration of a standard dose of albuterol at Visit 2 (albuterol MDI, 90 µg per inhalation, 2 to 4 actuations, with or without a spacer, or up to 2.5 mg of nebulized albuterol). Patients can return to the clinic once within 7 days for a 2nd attempt at reversibility if the first attempt was =12 % but <15%. This 2nd attempt must be done in the morning. Until the reversibility criterion is met, the patient must not be withdrawn from his/her usual ICS and must not be dispensed run-in medication, study reliever medication, or patient notebook and diary. The run-in period cannot start until after the FEV1 and reversibility criteria have been met. 6. Has required and received treatment with a consistent daily dose of ICS within the corresponding dose range listed below for at least 4 weeks prior to Visit 1. If the patient is not under the care of the investigator, documentation of ICS use by pharmacy records or copies of the prescribing Health Care Practitioner’s records are required, to verify ICS use. - Beclomethasone dipropionate HFA pMDI: 160 - 320 µg/day - Budesonide: 360 - 540 µg/day - Budesonide (nebulized): 1000 µg/day - Flunisolide: 1000 - 1250 µg/day - Flunisolide HFA: 320 µg/day - Fluticasone 176 - 352 µg/day (HFA pMDI) or 200-400 µg/day (Diskus) - Triamcinolone acetonide: =600 - 900 µg/day - Ciclesonide: 320 - 480 µg/day - Mometasone: 440 µg/day Note: Other non-steroidal asthma medications (eg, leukotriene modifiers, mast cell stabilizers) could have been used in combination with any of the above and would not impact a patient’s eligibility. After providing written informed consent for withdrawal of medication and at least 48 hours prior to spirometry testing, potential patients maintained on a fixed combination of ICS and LABA should be switched to a comparable dose of ICS without the addition of a longterm ß2-agonist. This change will not be considered a change in the dose of maintenance ICS. 7. If receiving inhalant allergen immunotherapy, the patient must have been on a stable maintenance regimen for at least 6 weeks and is expected to remain on immunotherapy throughout the study. Randomization criteria (Visit 3) 1. Has discontinued use of all asthma medications, including all formulations of ß2-agonists, following Visit 2 (or since meeting the FEV1/reversibility criteria, if met after Visit 2) and used o
Exclusion criteria
Exclusion criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Has been hospitalized for >24 hours at least once or has required emergency treatment more than once in an emergency department (or equivalent) for acute deterioration of asthma 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 participated in another investigational drug study during the 4 weeks prior to Visit 1. 4. Has participated in a prior Symbicort clinical study within the previous 12 months. 5. Is receiving treatment with a ß-blocker (including eye drops). 6. Has taken Xolair®, or any other monoclonal or polyclonal antibody therapy, for any reason within the 6 months prior to Visit 2. 7. Positive pregnancy test at any time during the study. 8. 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. 9. Has a planned hospitalization during the study. 10. Has any clinically relevant abnormal findings on physical examination or vital signs at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study. 11. Has known or suspected hypersensitivity to study medications and/or their excipients. Exclusion criteria at randomization (Visit 3) 1. Has been treated with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason during the run-in period or at time of Visit 3. 2. Has been hospitalized for >24 hours or has required emergency treatment in an emergency department (or equivalent) for acute deterioration of asthma during the run-in period. 3. Has a respiratory infection or other viral/bacterial illness or is recovering from such an illness at the time of Visit 3, which, in the investigator’s opinion, will interfere with the patient’s lung function and/or ability to perform serial spirometry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the bronchodilating effects of 3 doses of formoterol given in combination with budesonide as Symbicort pMDI in a population of asthmatic children demonstrated to be stable on a medium dose range of ICS therapy.;Secondary Objective: The secondary objectives of this study are to: • evaluate the bronchodilating effect of Foradil Aerolizer (formoterol fumarate inhalation powder; Schering) 12 µg • determine the systemic exposure to formoterol following administration of formoterol 2.25 µg, 4.5 µg, and 9 µg, given in combination with budesonide as Symbicort pMDI or Foradil Aerolizer 12 µg.;Primary end point(s): Outcome variable(s): • Efficacy - The primary efficacy variable will be AUC0-12 for FEV1. - The secondary efficacy variables are FEV1 at 12 hours after study medication inhalation and the maximal FEV1 for the 12-hour study period. • Pharmacokinetics - 12-hour urine collection to measure unchanged formoterol • Safety - Incidence of adverse events, discontinuations due to adverse events, serious adverse events | — |
Countries
Hungary
Outcome results
None listed