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NCT06272370CompletedPhase 4

Individualizing Treatment for Asthma in Primary Care

Source: ClinicalTrials.gov · Last updated 20 Apr 2025

Brief summary (registry, in English)

This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
103 (actual)
First submitted
10 Feb 2024
Start date
1 Feb 2024
Primary completion date
30 Sept 2024
Lead sponsor
DARTNet Institute
Diseases
Asthma
NCT number
NCT06272370

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 103
  • From 1 Feb 2024 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • On daily or every other day oral steroids for any reason;
  • Currently on R-ICS or AZ therapy. Individuals on biologics can be enrolled if they have been on a stable dose for \> 6 months and meet the ACT or exacerbation criteria as well as all other criteria.
  • Specified medications for which close monitoring has been recommended in the setting of macrolide administration (digoxin, warfarin, theophylline, ergotamine or dihydroergotamine, cyclosporine, hexobarbital, phenytoin or nelfinavir).

Other illness

  • Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer;

Lab values

  • 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 hypomagnesemia; clinically significant bradycardia; or history of prolonged cardiac repolarization and QT interval or torsades de pointes);
  • 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) or possible risk (i.e., can cause prolonged QT but lacks evidence for risk of torsades de pointes when taken as recommended) - Full lists in Appendix 1.

Other

  • 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);

Who the study is looking for

  • A clinical asthma diagnosis for at least 1 year;
  • 12-75 years of age;
  • A current ACT total score of \<20 OR an exacerbation requiring 72 hours or more of parenteral steroids or a hospitalization of at least 24 hours \> 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 inclusion criteria.)
  • 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 smoker with obstruction on PFTs, but normal diffusing capacity of the lungs for carbon monoxide (DLCO) in the past 24 months.

Age in the registry: 12 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
DARTNet Insitute
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.