Asthma study: Inhaled corticosteroid vs Azithromycin
Official title Individualizing Treatment for Asthma in Primary Care (Full Study)
ClinicalTrials.gov ID: NCT07052942
What this study is testing
What is Inhaled corticosteroid (ICS)?
This is an investigational approach using inhaled steroid medicines that is being studied to help manage asthma symptoms. It is designed to reduce swelling and irritation in the airways of the lungs.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether two different medicine plans work better for preventing asthma attacks. It also checks if using them together is helpful.
- Who it's for
- You may be able to join if you have asthma and see a primary care doctor.
- What's involved
- You would use inhaled steroids or take a medicine called azithromycin. You might use one plan or both plans together.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 75
You may be able to join if
- A clinical asthma diagnosis for at least 1 year;
- 13-75 years of age;
- A prescription for an ICS either used regularly, or on an as needed controller, not reliever, schedule - ICS or ICS + LABA or ICS+LABA+LAMA;
- A current ACT total score of \ 30 days and \< 365 days prior to enrollment;
- Able to provide consent (adolescents: assent) in English or Spanish
You likely can't join if
- Another family member living in the same household already enrolled in study;
- Life expectancy \<1 year (operationalized by the question to the patient's asthma care clinician "Would you be surprised if this person died in the...
- No ICS prescribed for the individual (does not have to be using the ICS inhaler);
- Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer (if participant is \> 12 months out from...
- Allergy to macrolides or conditions for which macrolide administration may possibly be hazardous (e.g., acute or chronic hepatitis, cirrhosis, or...
- On daily or every other day oral steroids for any reason;
See the full eligibility criteria
- A clinical asthma diagnosis for at least 1 year;
- 13-75 years of age;
- A prescription for an ICS either used regularly, or on an as needed controller, not reliever, schedule - ICS or ICS + LABA or ICS+LABA+LAMA;
- A current ACT total score of \ 30 days and \< 365 days prior to enrollment;
- Able to provide consent (adolescents: assent) in English or Spanish; (i.e., cognitively impaired individuals are deemed not to be able to provide consent and thus do not meet .);
- Patients with a coexisting clinical diagnosis of COPD are eligible if they meet any one of the following criteria: (i) Never smoker without secondary lung disease causing airway obstruction.
- Patients on medications that may interact with azithromycin but are not totally excluded may be enrolled if they agree to a cardiac rhythm strip after consent and prior to randomization (or have an ECG within the prior...
- Another family member living in the same household already enrolled in study;
- Life expectancy \<1 year (operationalized by the question to the patient's asthma care clinician "Would you be surprised if this person died in the next 12 months? If yes - include, if no - exclude);
- No ICS prescribed for the individual (does not have to be using the ICS inhaler);
- Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer (if participant is \> 12 months out from original therapy and may be on a cancer maintenance drug that is not...
- Allergy to macrolides or conditions for which macrolide administration may possibly be hazardous (e.g., acute or chronic hepatitis, cirrhosis, or other liver disease; end-stage renal disease
- On daily or every other day oral steroids for any reason;
- A course of systemic steroids for an asthma exacerbation or an overnight hospitalization for an asthma exacerbation in the past month (can wait and re-check eligibility after one month);
- Currently on R-ICS or any antibiotic therapy expected to last more than 30 days. If on antibiotics less than 30 days, individual can enroll after they have stopped their current antibiotic for 72 hours.
- On a medication with known risk (i.e., that is associated with prolonged QT and associated with torsades de pointes even when taken as recommended)- absolute contraindication to eligibility- Full lists in Appendix B;
- Specified medications for which close monitoring has been recommended in the setting of macrolide administration (digoxin, warfarin, theophylline, ergotamine or dihydroergotamine, cyclosporine, hexobarbital, phenytoin...
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Worcester, Massachusetts, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Worcester, Massachusetts, United States; New Brunswick, New Jersey, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Charlotte, North Carolina, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.