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Anti-biotic

Enhanced Usual Care for Immune System Disorders (iTREAT-PC Trial)

Phase 4

Recruiting

Led By David T Mauger, PhD

Research Sponsored by DARTNet Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A clinical asthma diagnosis for at least 1 year

12-75 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up total follow-up period is up to 3 months per participant.

Awards & highlights

iTREAT-PC Trial Summary

"This trial is testing different treatments for teenagers and adults with asthma. Participants will be randomly assigned to one of four groups: enhanced usual care, rescue inhaled corticosteroids, azithromycin

Who is the study for?

This trial is for teenagers and adults with asthma. Participants should have a history of the condition but specifics about what makes someone eligible or ineligible are not provided.Check my eligibility

What is being tested?

The study tests four approaches: enhanced usual care, rescue inhaled corticosteroids, azithromycin pills, and a combination of both drugs. Everyone gets access to an online tool for monitoring asthma symptoms.See study design

What are the potential side effects?

Inhaled steroids can cause throat irritation, coughing, and hoarseness. Azithromycin may lead to stomach upset, diarrhea, and in rare cases hearing problems or allergic reactions.

iTREAT-PC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with asthma for over a year.

Select...

I am between 12 and 75 years old.

iTREAT-PC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ total follow-up period is up to 3 months per participant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~total follow-up period is up to 3 months per participant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and total follow-up period is up to 3 months per participant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids).

Secondary outcome measures

Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire

Asthma control as measured by the Asthma Control Test

Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma.

Side effects data

From 2010 Phase 1 trial • 15 Patients • NCT01169038

13%

Headache

13%

Arthalgias

Insomnia

hypotension

leucopenia

pneumonia

rash

100%

80%

60%

40%

20%

Study treatment Arm

Antibiotics

iTREAT-PC Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Usual CareExperimental Treatment1 Intervention

Participants will be asked to use an online Asthma Symptom Monitoring tool to enhance communication with the medical team as well as self-awareness of their asthma symptoms. There are no "study drugs" in this arm. All 4 arms of the study will use these tools

Group II: AzithromycinActive Control1 Intervention

Participants will use azithromycin (Zithromax) 500mg three times a week (10mg.kg for participants under 50Kg) which can be dropped to 250 mg three times a week for dose related side effects

Group III: Rescue Inhaled CorticosteroidsActive Control1 Intervention

Participants in this arm will either have budesonide/formoterol (Symbicort) or mometasone/formoterol (Dulera), or a stand-alone ICS (beclomethasone/QVAR, or budesonide/Pulmicort, or fluticasone Flovent HFA, Flovent Diskus, ArmonAir RespiClick, Arnuity Ellipta, or mometasone, Asmanex HFA, Asmanex Twisthaler or ciclesodine Alvesco HFA) added to the participants usual treatment or a combination inhaler of corticosteroid and albuterol (AirSupra) that was recently approved

Group IV: Rescue Inhaled Corticosteroids and azithromycinActive Control2 Interventions

This arm includes both the inhaled corticosteroid comparator and the azithromycin comparator as described in those two arms Participants in this arm will either have budesonide/formoterol (Symbicort) or mometasone/formoterol (Dulera), or a stand-alone ICS (beclomethasone/QVAR, or budesonide/Pulmicort, or fluticasone Flovent HFA, Flovent Diskus, ArmonAir RespiClick, Arnuity Ellipta, or mometasone, Asmanex HFA, Asmanex Twisthaler or ciclesodine Alvesco HFA) added to the participants usual treatment or a combination inhaler of corticosteroid and albuterol (AirSupra) that was recently approved AND Participants will use azithromycin (Zithromax) 500mg three times a week (10mg.kg for participants under 50Kg) which can be dropped to 250 mg three times a week for dose related side effects

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North CarolinaOTHER

167 Previous Clinical Trials

1,449,502 Total Patients Enrolled

Penn State UniversityOTHER

355 Previous Clinical Trials

125,632 Total Patients Enrolled

RANDOTHER

137 Previous Clinical Trials

510,126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this ongoing medical study?

"As per the details on clinicaltrials.gov, this research endeavor is presently seeking candidates. The trial was initially made public on February 1st, 2024 and underwent its most recent update on February 20th, 2024."

Answered by AI

Which category of individuals would be considered ideal candidates for participation in this clinical trial?

"Patients aged between 12 and 75 with bronchial ailments are eligible for enrollment in this study, which has a capacity for admitting up to 125 participants."

Answered by AI

What is the current number of individuals being recruited for participation in this research study?

"Indeed, the details on clinicaltrials.gov imply that this research endeavor is actively seeking individuals to take part. The trial was originally posted on February 1st, 2024 and underwent its latest update on February 20th, 2024. A total of 125 participants are being sought from a single site."

Answered by AI

Does the FDA endorse Enhanced Usual Care as a treatment option?

"Given that this trial is categorized as Phase 4 and the treatment is already approved, our team rates Enhanced Usual Care with a safety score of 3."

Answered by AI

Is there an age limit regarding the participation of individuals younger than 40 in this research study?

"Individuals aged between 12 and 75 years are eligible for participation in this research. Notably, there are a total of 276 trials available for minors under the age of consent and 779 studies open to elderly individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Individualizing Treatment for Asthma in Primary Care

2024. "Individualizing Treatment for Asthma in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06272370.

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