Chronic infection with Chlamydia pneumoniae in asthma: a type-2 low infection related phenotype.
Doriane Calmes, Pascale Huynen, Virginie Paulus...
https://pubmed.ncbi.nlm.nih.gov/33637072Actively Recruiting
Led by DARTNet Institute · Updated on 2025-10-29
3200
Participants Needed
13
Research Sites
N/A
Total Duration
D
DARTNet Institute
Lead Sponsor
P
Penn State University
Collaborating Sponsor
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 corticosteroid/formoterol 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)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
Total: 13 locations
1
DARTNet Institute
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University Colorado-Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
AdventHealth
Orlando, Florida, United States, 32803
Not Yet Recruiting
4
University of Kansas
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
5
Reliant Medical Group
Worcester, Massachusetts, United States, 01608
Actively Recruiting
6
University of Missouri
Columbia, Missouri, United States, 65211
Not Yet Recruiting
7
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
8
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
9
University North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Atrium Health
Charlotte, North Carolina, United States, 28207
Actively Recruiting
11
JPS Health Network
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
12
Kelsey Research Foundation
Houston, Texas, United States, 77005
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98105
Not Yet Recruiting
B
Brian K Manning, MPH
J
Joel Shields, MA
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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