Inhalation Treatments for Asthma
(VENTURI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new inhalation treatments for individuals with poorly controlled asthma. The study compares two inhaler medications: Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide and Fluticasone furoate/Umeclidinium/Vilanterol. Researchers aim to assess how effectively these medications deliver drugs to both large and small airways in the lungs. Participants will use each treatment for a set period, with a break in between, to evaluate their effectiveness. Individuals who have had asthma for over a year and continue to experience symptoms despite using inhalers may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in asthma treatment.
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it mentions a 'washout period' for bronchodilators before certain tests. It's best to discuss your current medications with the trial team to get specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both treatments in this trial, Trimbow and Trelegy Ellipta, have undergone safety studies.
Trimbow combines three drugs: beclometasone (a steroid), formoterol (a bronchodilator), and glycopyrronium (an anticholinergic). These ingredients are generally well-tolerated. Long-term use of similar treatments in people with breathing problems has demonstrated their safety and tolerance over time.
Trelegy Ellipta also combines three drugs and has proven effective with a good safety record. It includes fluticasone (a steroid), umeclidinium (an anticholinergic), and vilanterol (a bronchodilator). A large study found it effective in over 92% of patients, with manageable side effects.
Both treatments have been used in people with uncontrolled asthma or similar conditions and are designed to help open up the airways. While no treatment is without side effects, these combinations have been well-studied and are considered safe for many users.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these asthma treatments because they offer unique combinations that might enhance symptom control. The beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (Trimbow) combines three active ingredients in a single inhaler, potentially improving convenience and adherence compared to using multiple inhalers. Meanwhile, the fluticasone furoate/umeclidinium/vilanterol (Trelegy) is a once-daily inhalation, which could make it easier for patients to maintain their treatment routine. Both combinations aim to optimize anti-inflammatory and bronchodilator effects, possibly offering superior control over asthma symptoms compared to current standard options.
What evidence suggests that this trial's treatments could be effective for asthma?
Research shows that both treatments in this trial could help improve asthma symptoms. Participants in one arm will receive Trimbow, which significantly improves lung function. For example, a measure of lung capacity called FEV1 increased from 57.75% to 75.10%. Trimbow proves more effective than two-drug therapies for people whose asthma is not well-controlled.
Participants in another arm will receive Trelegy Ellipta, which effectively reduces asthma flare-ups and the need for extra medications. Studies have shown it improves asthma symptoms and lung function, even for patients who haven't succeeded with other treatments. Both treatments offer potential benefits for people struggling to control their asthma.36789Are You a Good Fit for This Trial?
This trial is for individuals with uncontrolled asthma. Participants should have a history of the condition and be currently experiencing symptoms that aren't well-managed by their current treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants are randomized to receive either BDP/FF/G or FluF/UMEC/VI for 8 weeks
Washout
Participants undergo a 4-week washout period using an unrelated maintenance ICS/LABA combination inhaler
Treatment Phase 2
Participants are crossed over to the other treatment they did not receive initially for another 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide
- Fluticasone furoate/Umeclidinium/Vilanterol
Trial Overview
The VENTURI study is testing two different inhaler medications to see how they affect both large and small airways in asthma patients: Trimbow (a combination of Beclometasone, Formoterol, and Glycopyrronium) and Trelegy Ellipta (combining Fluticasone, Umeclidinium, and Vilanterol).
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Active Control
For this randomized arm, Trimbow pMDI (BDP/FF/G 100/6/12.5 mcg), will be administered as two inhalations twice-daily 8 weeks following randomization.
Following the washout period, participants that were randomized to receive Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg) will be crossed over to receive Trimbow pMDI ( BDP/FF/G 100/6/12.5 mcg) for 8 weeks.
For this randomized arm, Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg), will be administered as one inhalation once daily for 8 weeks following randomization. .
Following the 8-week treatment period, participants will be placed on an ICS/LABA therapy unrelated to study medications during a 4-week wash-out period prior to cross-over.
Following the washout period, participants that were randomized to receive Trimbow pMDI( BDP/FF/G 100/6/12.5 mcg) will be crossed over to receive Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg) for 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
Real-World Efficacy of Beclomethasone Dipropionate/ ...
Results: After three months, significant improvements were observed in FEV1 (from 57.75 ± 12.30% to 75.10 ± 18.94%, p < 0.001) and FEF25-75 ( ...
Single inhaler with beclometasone, formoterol, and ...
Recent literature has shown that triple therapy is more effective than dual therapy for individuals with uncontrolled asthma.
Real-world effectiveness of beclomethasone/formoterol ...
Conclusion: Real-world evidence showed that BDP/FF/G Nexthaler improved symptoms, lung function, EQ-5D, and adherence after switching from dual therapy.
Cost-effectiveness of single-inhaler extrafine ...
One SITT is the extrafine formulation of beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G). We used data from two 52-week clinical trials ...
Fixed Triple Inhaled Combination in Asthmatic Patients in a ...
Each metered dose (the dose leaving the valve) contains 200 μg of beclometasone dipropionate, 6 μg of formoterol fumarate dihydrate and 10 μg of glycopyrronium ...
Beclomethasone dipropionate, formoterol fumarate and ...
This study characterized the interaction between the ICS beclomethasone dipropionate, the LABA formoterol fumarate and the LAMA glycopyrronium bromide in human ...
NCT05898984 | Clinical Study to Evaluate the Safety, ...
The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB ...
Long-term safety and efficacy of glycopyrrolate/formoterol ...
Results confirmed the long-term safety and tolerability of GFF MDI 18/9.6 μg BID in COPD. •. Improvements in efficacy endpoints were sustained over 52 weeks.
High-risk adverse events in two types of single inhaler ...
Results: 16,355 AEs in BUD/GLY/FOR and 39,110 AEs in FF/UMEC/VI were extracted. Device use issues, oropharyngeal and vocal problems, pneumonia, ...
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