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Anti-biotic

Individualized Treatments for Asthma (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

Must not have

Currently on R-ICS or AZ therapy

No ICS prescribed for the individual

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with asthma for over a year.

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I am between 12 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking R-ICS or AZ medication.

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I am not prescribed inhaled corticosteroids.

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I am currently being treated for cancer, excluding basal or skin squamous cell cancer.

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I take oral steroids daily or every other day.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 6Eligibility criteria met