Condition: Asthma · Sponsor: AstraZeneca
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The purpose of this study is to evaluate the effect of 2 different GP metered dose inhaler (MDI) doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in participants 4 to less than 12 years of age with asthma.
This description comes directly from the study's public registry record.
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Main Inclusion Criteria: * Participants who have a documented history of physician-diagnosed asthma * Participants who have been using a stable and regular inhaled corticosteroid plus one additional asthma controller medication. * Participants must have a Childhood Asthma Control Test score ≥ 19. * Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value. * Body mass index (BMI) ≤ 95 percentile for age and body weight of ≥ 14 kg or higher. * Female participants who experience menarche must have a negative urine pregnancy test. * Received no asthma medication other than run-in BFF MDI BID and albuterol/salbutamol as needed. Main Exclusion Criteria: * Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). * Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary. * Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG. * Hospitalization for asthma * Narrow-angle glaucoma not adequately treated and/or change in vision, bladder dysfunction, bladder outlet obstruction/urinary retention or any other conditions where anticholinergic treatment is contraindicated and may be relevant. * Use of Long-acting muscarinic antagonist (LAMA), either alone or as part of an inhaled combination therapy. * Current use of any systemic beta-blockers. * Respiratory infection involving antibiotic treatment. * Systemic corticosteroid use for any reason (including asthma exacerbations). * Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI. * Participants who are medically unable to withhold their short-acting bronchodilators and other asthma medications. * Any use of marketed (eg, omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic. * Regular use of a nebulizer or a home nebulizer for receiving asthma medications. * Use of any immunomodulators or immunosuppressive medication.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Research Site | Bakersfield, California, United States | Not Yet Recruiting |
| Research Site | Long Beach, California, United States | Not Yet Recruiting |
| Research Site | San Diego, California, United States | Not Yet Recruiting |
| Research Site | Miami, Florida, United States | Not Yet Recruiting |
| Research Site | Pembroke Pines, Florida, United States | Not Yet Recruiting |
| Research Site | Owensboro, Kentucky, United States | Recruiting |
| Research Site | Lafayette, Louisiana, United States | Not Yet Recruiting |
| Research Site | Boston, Massachusetts, United States | Not Yet Recruiting |
| Research Site | Columbia, Missouri, United States | Not Yet Recruiting |
| Research Site | Cincinnati, Ohio, United States | Not Yet Recruiting |
| Research Site | Oklahoma City, Oklahoma, United States | Not Yet Recruiting |
| Research Site | Buenos Aires, Argentina | Not Yet Recruiting |
+ 27 more locations — full list on the registry record.
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