BridgeMD
A Variable Length Study to Evaluate the Efficacy and Safety of Budesonide/Glycopyrronium/Formoterol inhaler in Adults and Adolescents with Severe Asthma Inadequately Controlled with Standard of Care.
EU CTIS ID: 2023-505786-88-00
What this study is testing
Main Objective of D5982C00008 1. To assess the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) relative to Budesonide and Formoterol Fumarate (BFF) MDI or Symbicort Pressurized MDI on lung function in participants with inadequately controlled asthma. Main Objective of Pooled Studies D5982C00007 and D5982C00008 1. To assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on asthma exacerbations in participants with inadequately controlled asthma.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
- eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
- No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.
- Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
- Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
- ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
You likely can't join if
- Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
- Use of oral beta2-agonist within 3 months of V1.
- Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.
- Hospitalization for asthma within 2 months of Visit 1.
- Known history of drug or alcohol abuse within 12 months of Visit 1.
- Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
See the full eligibility criteria
Who can join
- 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
- eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
- No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.
- Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
- Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
- ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
- FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization) • Participants > and/or = 18 years of age: < 80% • Participants 12 to <18 years of age: < 90%
- FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL. • Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3. • Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
- Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
- Demonstrate acceptable MDI/pMDI administration technique.
- Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
What rules you out
- Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
- Use of oral beta2-agonist within 3 months of V1.
- Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.
- Hospitalization for asthma within 2 months of Visit 1.
- Known history of drug or alcohol abuse within 12 months of Visit 1.
- Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
- Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.
- Participation in another clinical study with a Study Intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other Study Intervention that is not identified in the protocol is prohibited for use during study duration.
- Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.
- Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
- For women only – currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator
- Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.
- Life-threatening asthma defined as a history of significant asthmaepisode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
- Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.
- Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
- Current evidence of COPD.
- Oral and IV corticosteroid use (any dose) within 4 weeks of V1. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study. Depot corticosteroid use for any reason within 3 months of V1.
- Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Turkey
- Israel
- Russian Federation
- South Africa
- China
- United States
- United Kingdom
- Brazil
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Turkey; Israel; Russian Federation; South Africa; China and 3 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 EU CTIS; the study team decides eligibility.