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New treatment option for Asthma
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)?
Inhaled corticosteroid (ICS) is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for asthma.
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
- While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma.
- 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; (i.e., cognitively impaired individuals are deemed not to be able to provide...
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. (ii) Current or former...
- 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; uncorrected hypokalemia or...
- 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. Individuals on...
- 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's taking place
- Aurora, Colorado, United States
- Orlando, Florida, United States
- Kansas City, Kansas, United States
- Worcester, Massachusetts, United States
- Columbia, Missouri, 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
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Aurora, Colorado, United States; Orlando, Florida, United States; Kansas City, Kansas, United States; Worcester, Massachusetts, United States; Columbia, Missouri, United States; New Brunswick, New Jersey, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.