Inhaled Corticosteroids and Beta2 Agonists for Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the causes of breathing problems in people with moderate to severe asthma, even when they are on medication. Researchers are testing different inhalers that combine corticosteroids (which reduce inflammation) and bronchodilators (which help open the airways) to assess their effects on the large and small airways in the lungs. The study will use tests such as measuring nitric oxide in the breath and detailed lung scans to detect inflammation and other changes in the lungs. Individuals with stable, treated asthma who experience frequent breathing issues might be suitable for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it mentions that treatment will include inhaled corticosteroids and other asthma medications, so you might continue with similar treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments being studied in this trial—Budesonide/Formoterol, Fluticasone/Salmeterol, and Mometasone/Formoterol—are generally safe for people with asthma.
For Budesonide/Formoterol, studies have found it effective and safe for long-term asthma treatment. A 12-week study demonstrated ongoing improvement in lung function without major safety concerns. Another study confirmed its safety over a year of use.
Fluticasone/Salmeterol has also been well-researched. Studies indicate that this combination does not significantly increase the risk of serious asthma-related issues. It helps improve breathing and control asthma symptoms without major safety problems.
Mometasone/Formoterol has been shown to be safe as well. Research found that adding Formoterol to Mometasone did not increase serious asthma-related risks. In fact, it reduced such events, making it a safe choice for many patients.
In summary, these treatments are well-studied and generally safe for people with asthma. They are designed to help control symptoms and improve lung function.12345Why are researchers excited about this trial?
Researchers are excited about the combination treatments of Budesonide/Formoterol, Fluticasone/Salmeterol, and Mometasone/Formoterol because they offer a targeted approach to managing moderate-severe persistent asthma. Unlike standard treatments that typically use a single method, these combinations use both a long-acting beta-2 agonist and a corticosteroid. This dual-action approach aims to reduce inflammation while simultaneously relaxing the muscles in the airways for better airflow. Additionally, the use of tiotropium alongside these treatments can further enhance lung function. This comprehensive strategy not only targets multiple pathways of asthma but also has the potential to improve quality of life more effectively than traditional treatments.
What evidence suggests that this trial's treatments could be effective for asthma?
Research shows that certain combination treatments can effectively manage asthma. In this trial, participants will receive one of the following treatments: budesonide/formoterol, fluticasone/salmeterol, or mometasone/formoterol. Budesonide/formoterol has improved asthma control and quality of life, with some patients feeling better as soon as four weeks after starting treatment. Fluticasone/salmeterol improves lung function and asthma control over time without increasing the risk of serious asthma-related issues. Mometasone/formoterol outperforms mometasone alone, enhancing lung function and reducing asthma flare-ups more quickly. Research supports these treatments, demonstrating their effectiveness in managing asthma symptoms.678910
Who Is on the Research Team?
Arthur F Gelb, MD
Principal Investigator
Arthur F Gelb Medical Corporation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inhaled corticosteroids and long-acting beta2 agonists and muscarinic antagonists to evaluate airflow limitation mechanisms
Exacerbation Evaluation
Spirometry and exhaled nitric oxide measurements are obtained during naturally occurring asthma exacerbations
Follow-up
Participants are monitored for safety and effectiveness after treatment, including optical coherence tomography and autopsy evaluations
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide/Formoterol
- Fluticasone/Salmeterol
- Mometasone/Formoterol
- Prednisone
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
All Asthmatics will be treated with 1 of 3 long acting beta 2 agonist + corticosteroid using low or medium dose of inhaled (Advair) fluticasone or equivalent corticosteroid 200-500mcg/day plus salmeterol 100 mcg/day or (Symbicort) budesonide 320-640 mcg +formoterol 18 mcg/day or (Dulera) mometasone 400-800mcg + formoterol 20 mcg/day. In addition tiotropium 18ucg/day will be used. Additionally, albuterol 0.083%/ipratropium 0.02% solution or MDI HFA for acute exacerbation.Will measure lung function and asthma quality of life questionaire
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Who Is Running the Clinical Trial?
Gelb, Arthur F., M.D.
Lead Sponsor
Citations
Real-Life Effectiveness of Budesonide/Formoterol as ...
The evidence from the real-life NOTOS study showed significant and clinically meaningful improvement in asthma control, lung function, and ...
Real-life effectiveness of budesonide/formoterol maintenance ...
Significant relief of asthma symptoms was observed as early as 4 weeks into budesonide⁄formoterol maintenance and reliever therapy, while ...
Inhaled Combined Budesonide–Formoterol as Needed in ...
This trial showed that budesonide–formoterol used as needed was a more effective treatment than a SABA alone in patients with mild asthma; ...
The whole story: treatment outcomes with Symbicort®
Combined long-term therapy with budesonide and formoterol also improves patient quality of life compared with budesonide alone. Two other factors associated ...
Outcomes and Usability of Formoterol-Budesonide ...
Clinical trials have demonstrated the efficacy and safety of budesonide/formoterol in enhancing lung function, decreasing exacerbations, and ...
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.
One-year safety and efficacy of budesonide/formoterol in a ...
Conclusions: Budesonide/formoterol in a single inhaler is as safe and effective in the long-term treatment of asthma as budesonide plus formoterol via separate ...
A 24-Week Efficacy and Safety Study to Assess ...
This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with ...
Controlled Trial of Budesonide–Formoterol as Needed for ...
In double-blind, placebo-controlled trials, budesonide–formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation ...
Efficacy and Safety Evaluation of Budesonide/Formoterol ...
The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective ...
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