Individualizing Treatment for Asthma in Primary Care

Asthma Clinical Trial

— iTREAT-PC  

Official title:

Individualizing Treatment for Asthma in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272370
• Other study ID #: PLACER-2021C3-24737-IC
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: DARTNet Institute
• Contact: Wilson D Pace, MD
• Phone: 8004340278
• Email: wilson.pace[@]dartnet.info
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Design. Current activities consist of a Feasibility study to test all activities prior to the full study. The Feasibility study will involve only 5 centers and each participant will be involved for only 3 months. The study will consist of a four arm, patient level randomized trial (N=125). Comparators: Rescue Inhaled Corticosteroids (R-ICS) versus azithromycin versus R-ICS plus azithromycin versus enhanced usual care patients. All arms will include home monitoring of asthma symptoms using various approaches. R-ICS therapy will consist of a corticosteriod/formoterol inhaler, or a stand-alone ICS inhaler used with usual rescue therapy or when available a combination corticosteroid/albuterol inhaler, the initial azithromycin dose will be 500mg (10mg/Kg) three times a week and may be titrated down to 250mg (10mg/Kg) three times per week for side effects. Exacerbations will be blindly adjudicated. Individuals who experience three exacerbations in < 12 months in the full study will have their treatments "stepped-up,"unless in the dual treatment arm; control participants going to R-ICS and single therapy participants to dual therapy. In the full study, after a step-up participants will be followed for an additional 12 months. There will be no step-up during the Feasibility phase. Individuals completing either of the azithromycin arms will be offered 6 additional months of follow-up after stopping the azithromycin only.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

1. A clinical asthma diagnosis for at least 1 year;

2. 12-75 years of age;

3. 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;

4. 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.)

5. 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.

Exclusion Criteria:

1. 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);

2. No ICS prescribed for the individual (does not have to be using the ICS inhaler);

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

4. 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);

5. On daily or every other day oral steroids for any reason;

6. 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.

7. 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.

8. 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).

Related Conditions & MeSH terms

• Asthma
• Bronchial Diseases
• Hypersensitivity
• Immune System Diseases
• Lung Diseases
• Lung Diseases, Obstructive
• Respiratory Hypersensitivity
• Respiratory Tract Infections

Intervention

Other:
• Asthma Symptom Monitoring online tools
All participants will be provided access to the Asthma Symptom Monitoring tools and 3/4's will be randomized to one of the other three arms above

Drug:
• Inhaled Steroids
participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid (beclomethasone, budesonide, fluticasone, mometasone, ciclesodine) of their choice with their current reliever therapy or be converted to budesonide/albuterol as rescue therapy
• Azithromycin Pill
Participants will take 500mg of azithromycin three times a week or 10mg/kg if under 50Kg which may be reduced to 250mg/Kg for side effects

Locations

Country	Name	City	State
United States	DARTNet Insitute	Aurora	Colorado

Sponsors (12)

Lead Sponsor	Collaborator
DARTNet Institute	Brigham and Women's Hospital, Icahn School of Medicine at Mount Sinai, Kelsey Research Foundation, Penn State University, RAND, Reliant Medical Group, Rutgers University, University of Colorado, Denver, University of North Carolina, University of Washington, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

Calmes D, Huynen P, Paulus V, Henket M, Guissard F, Moermans C, Louis R, Schleich F. Chronic infection with Chlamydia pneumoniae in asthma: a type-2 low infection related phenotype. Respir Res. 2021 Feb 26;22(1):72. doi: 10.1186/s12931-021-01635-w. — View Citation

Global Initiative for Asthma. Global strategy for asthma management and prevention 2023 report. Accessed February 10, 2024. https://ginasthma.org/2023-gina-main-report/

Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26. — View Citation

Ray A, Camiolo M, Fitzpatrick A, Gauthier M, Wenzel SE. Are We Meeting the Promise of Endotypes and Precision Medicine in Asthma? Physiol Rev. 2020 Jul 1;100(3):983-1017. doi: 10.1152/physrev.00023.2019. Epub 2020 Jan 9. — View Citation

Wenzel SE. Severe Adult Asthmas: Integrating Clinical Features, Biology, and Therapeutics to Improve Outcomes. Am J Respir Crit Care Med. 2021 Apr 1;203(7):809-821. doi: 10.1164/rccm.202009-3631CI. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids).	Defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year. For this pilot each participant will only be followed for 3 months as this is testing the study processes. Exacerbation rates will be calculated based on 0.25 year per participant.	Total follow-up period is up to 3 months per participant.
Secondary	Asthma control as measured by the Asthma Control Test	Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The Asthma Control Test has a score range of 5 to 25 with higher scores indicating better control.	Total follow-up period is up to 3 months per participant.
Secondary	Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire	A measure of quality of life based on asthma symptoms with 15 questions the score ranges from 15 to 105 with higher scores representing better quality of life analysis would capture the risks and benefits for the interventions from the patient's point of view. developed entirely from patient experiences. Patients will be asked to assign a relative value to different health states.	Total follow-up period is up to 3 months per participant.
Secondary	Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma.	Days not able to work or go to school because of asthma symptoms OR days not able to carry our usual activities due to asthma. One question with scores ranging from 0 to 31 with lower scores being better.	Total follow-up period is up to 3 months per participant.