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Compares treatment options for Asthma
Official title A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma
ClinicalTrials.gov ID: NCT07525375
What this study is testing
What is GP MDI?
GP MDI is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 11
You may be able to join if
- Main
- 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.
You likely can't join if
- Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest...
- Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological...
- 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...
- Use of Long-acting muscarinic antagonist (LAMA), either alone or as part of an inhaled combination therapy.
See the full eligibility criteria
- Main
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Long Beach, California, United States
- San Diego, California, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Owensboro, Kentucky, United States
- Lafayette, Louisiana, United States
- Boston, Massachusetts, United States
- Columbia, Missouri, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Buenos Aires, Argentina
- CABA, Argentina
- La Plata, Argentina
- Lanús Este, Argentina
- Lobos, Argentina
- Mar del Plata, Argentina
- Mendoza, Argentina
- Rosario, Argentina
- San Juan Bautista, Argentina
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Long Beach, California, United States; San Diego, California, United States; Miami, Florida, United States; Pembroke Pines, Florida, United States; Owensboro, Kentucky, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.