Budesonide + Formoterol for Asthma
(COMPAIR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and effectiveness of two different inhaler formulas for children with asthma. The study involves two treatments: Budesonide, a corticosteroid, and Formoterol, a long-acting bronchodilator, both delivered through inhalers. It aims to understand how the body absorbs these medicines. Children who have had asthma for at least three months and are on a stable asthma treatment might be suitable candidates. Participants will use each inhaler in different sequences to determine which works better. As a Phase 1 trial, the research focuses on understanding how the treatment functions in people, offering participants a chance to contribute to early-stage medical research.
Do I have to stop taking my current medications for the trial?
The trial requires that you stay on a stable dose of your current asthma medication for at least 4 weeks before starting. If you're on a medication not listed in the trial's criteria, you might need to change it.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that the combination of budesonide and formoterol is safe for people with asthma. Research indicates that budesonide-formoterol does not cause more unwanted side effects compared to other treatments. Additionally, one study found that serious asthma-related problems occurred less frequently with this combination than with other therapies.
The FDA has already approved this treatment for older children and adults with asthma, indicating it has passed important safety checks for these groups. Although this study is just beginning, prior approval offers some assurance of its safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Budesonide and Formoterol for treating asthma because it offers a dual approach not commonly found in all standard treatments. Budesonide is a powerful anti-inflammatory medication, while Formoterol is a fast-acting bronchodilator. This combination works quickly to open the airways and reduce inflammation, potentially offering faster relief and better control of asthma symptoms compared to treatments that use these agents separately. Unlike standard treatments that might focus solely on inflammation or bronchodilation, this pairing targets both, which can improve overall management of asthma.
What evidence suggests that Budesonide and Formoterol might be an effective treatment for asthma?
This trial will compare two formulations of the budesonide and formoterol combination. Research has shown that using budesonide and formoterol together effectively manages asthma. Studies have found that this combination reduces the need for oral steroids and emergency room visits due to asthma attacks. People using budesonide-formoterol experience better lung function and fewer severe asthma flare-ups. Some notice benefits soon after starting, such as easier breathing. Overall, this treatment leads to better asthma control and fewer complications.26789
Are You a Good Fit for This Trial?
This trial is for children aged 4 to under 12 years old who have had asthma diagnosed by a doctor for at least 3 months. They must weigh at least 15 kg, not be severely overweight, and use certain asthma medications. Girls who have started menstruating need a negative pregnancy test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single dose of either Symbicort Aerosphere or Symbicort pMDI
Washout
A washout period between treatment periods
Treatment Period 2
Participants receive a single dose of the alternate treatment (Symbicort Aerosphere or Symbicort pMDI)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide
- Formoterol
Trial Overview
The study compares how the combination medicine budesonide/formoterol moves through the body when given with two different inhaler devices (Aerosphere vs. pMDI) in children with asthma.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
In study period 1, participants will receive a single dose of treatment B (reference formulation) and in study period 2, participants will receive a single dose of treatment A (test formulation).
In study period 1, participants will receive a single dose of treatment A (test formulation) and in study period 2, participants will receive a single dose of treatment B (reference formulation).
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
Comparative effectiveness of budesonide-formoterol ...
Conclusions: Asthma exacerbation was lower for BFC versus FSC initiators due to lower rates of oral corticosteroid use and asthma-related emergency department ...
Comparative Effectiveness of Budesonide-Formoterol ...
Asthma exacerbation was lower for BFC versus FSC initiators due to lower rates of oral corticosteroid use and asthma-related emergency department visits.
Inhaled Combined Budesonide–Formoterol as Needed in ...
In conclusion, this trial showed that budesonide–formoterol used as needed was superior to the SABA terbutaline used as needed both for asthma ...
4.
physiciansweekly.com
physiciansweekly.com/post/improved-asthma-outcomes-with-budesonide-formoterol-therapyImproved Asthma Outcomes With Budesonide/Formoterol ...
The results showed that among 1,107 individuals, significant clinical improvements were seen at 6 months in ACQ-6 scores [mean change −1.55 (95% ...
The Efficacy of Budesonide-formoterol in Patients with ...
The combination therapy led to improved clinical outcomes, including enhanced pulmonary ventilation function and reduced inflammatory markers.
Efficacy and safety of maintenance and reliever ...
The SMART regimen has a favourable risk-to-benefit profile and can be recommended for use in adults at risk of severe asthma exacerbations.
Asthma Clinical Trial Data for SYMBICORT® (budesonide ...
Sustained improvement in lung function was demonstrated in asthma patients ≥12 years of age in a 12-week efficacy and safety study.
Efficacy and Safety of As-Needed Budesonide-Formoterol ...
In adolescents with mild asthma, as-needed budesonide-formoterol reduced the risk of severe exacerbations versus short-acting β2-agonist alone, with similar ...
Articles Efficacy and safety of maintenance and reliever ...
The primary outcome was the proportion of participants with at least one high-use episode of β agonist (more than eight actuations per day of budesonide– ...
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