Severe Adult Asthmas: Integrating Clinical Features, Biology, and Therapeutics to Improve Outcomes.
Sally E Wenzel
https://pubmed.ncbi.nlm.nih.gov/33326352/Actively Recruiting
Led by DARTNet Institute · Updated on 2025-10-29
3200
Participants Needed
13
Research Sites
N/A
Total Duration
Researchers are studying different ways to reduce asthma exacerbations in primary care patients who have persistent asthma. This study compares two treatment approaches using inhaled corticosteroids ICS as rescue therapy, known as MART or PARTICS therapy, and using the antibiotic azithromycin as a preventive treatment. The study aims to find the best way to tailor asthma treatment to individual patient needs while monitoring for long-term side effects of ICS use. The study randomly assigns 3200 participants into four groups one using rescue inhaled corticosteroids R-ICS alone, one using azithromycin alone, one using both R-ICS and azithromycin, and a control group receiving enhanced usual care. R-ICS treatment includes corticosteroidformoterol inhalers or stand-alone ICS inhalers combined with usual rescue therapy. Azithromycin is given three times a week, starting at 500mg and possibly reduced to 250mg if side effects occur. All participants use a web-based Asthma Symptom Monitoring tool to track symptoms and communicate with their care team. Participants will be followed for up to 16 months to measure the rate of asthma exacerbations per year and assess asthma control, quality of life, and days lost from work or school due to asthma. The study collects symptom data weekly through the monitoring app, and exacerbations are reviewed blindly. Those experiencing frequent exacerbations may have their treatment adjusted. Participants completing azithromycin treatment may be followed for an additional 12 months after stopping the drug to monitor outcomes and safety.
CONDITIONS
Individualizing Treatment for Asthma in Primary Care (Full Study)
B
Brian K Manning, MPH
J
Joel Shields, MA
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DARTNet Institute
Lead Sponsor
Penn State University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | R‑ICS only | Azithromycin only | Enhanced usual care | R‑ICS + Azithromycin | ICS‑formoterol MART (guideline care) |
|---|---|---|---|---|---|
| What it is | Use of inhaled corticosteroid delivered as-needed as rescue therapy alone | Add‑on therapy with azithromycin dosing multiple times per week | Enhanced usual care based on standard ICS‑controller regimen | Combination of R‑ICS and azithromycin therapies together | Maintenance‑and‑reliever therapy with low‑dose ICS‑formoterol is now the preferred guideline strategy |
| Primary use | Rescue monotherapy per symptom | Add‑on anti‑inflammatory antibiotic treatment | Standard asthma management plus enhancements per protocol | Combined R‑ICS and azithromycin add‑on approach | Used as both daily controller and as-needed reliever per guidelines |
| Evidence status | Investigated in trial but broader efficacy compared to guideline care unclear | Investigated in trial; long‑term azithromycin shown to reduce exacerbations in other studies | Represents standard of care baseline; evidence for control exists in usual care literature | Combination approach under study; no published results yet | Strong evidence supports reduced exacerbations and improved control with MART in adults |
| Important limitations | Effectiveness compared to daily controller or MART not yet known | Antibiotic use raises resistance concerns and requires ECG monitoring | May not reflect real‑world care variations across settings | Adds complexity of combining two interventions; safety and adherence data pending | Not part of trial comparison so indirect relevance only |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 months
Participants receive one of the following interventions: inhaled corticosteroids as rescue therapy, azithromycin, both inhaled corticosteroids and azithromycin, or enhanced usual care. All participants will use an online Asthma Symptom Monitoring tool weekly to track symptoms and communicate with their care team.
Weekly symptom monitoring with web application; visits and assessments as scheduled by the care team
Duration - Up to 12 months after treatment ends
Participants who complete the azithromycin treatment arms may be offered up to 12 additional months of follow-up after stopping azithromycin to monitor asthma control and quality of life.
Periodic follow-up visits depending on treatment arm
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Sally E Wenzel
https://pubmed.ncbi.nlm.nih.gov/33326352/Anuradha Ray, Matthew Camiolo, Anne Fitzpatrick...
https://pubmed.ncbi.nlm.nih.gov/31917651/Elliot Israel, Juan-Carlos Cardet, Jennifer K Carroll...
https://pubmed.ncbi.nlm.nih.gov/35213105/Doriane Calmes, Pascale Huynen, Virginie Paulus...
https://pubmed.ncbi.nlm.nih.gov/33637072/DARTNet Institute
Lead Sponsor
Penn State University
Collaborating Sponsor