Status:
NOT_YET_RECRUITING
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Moderate-to-Severe Asthma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this trial test two known effective asthma strategies. Treatment guidelines recommend combination therapy of inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) inhaled me...
Detailed Description
Asthma affects 25 million people in the USA with a disproportionate effect on African American/Black (AA/B) and Hispanic/Latinx (H/L) patients. Inhaled corticosteroids are the backbone of asthma thera...
Eligibility Criteria
Inclusion
- Clinician diagnosis of asthma for ≥1 year;
- Age at enrollment--18-75 years old inclusive;
- One or more AEXs that occurred \< 12 months prior to enrollment. An AEX is defined as an asthma deterioration that either requires 72 hours or more of an oral or parenteral steroids OR a hospital stay for more than 24 hours for asthma. In the case of patients on biologics for asthma, the exacerbation must have also occurred after at least 6 months of biologic therapy;
- Currently prescribed an ICS/LABA containing preparation containing at least the lowest dose of ICS described in Table 2 as regular daily maintenance therapy for at least one month;
- Has a rescue SABA containing inhaler that they have used on average at least once a month.
- Able to provide consent in English for the feasibility study or in English or Spanish for the full study.
Exclusion
- Life expectancy \<2 years;
- COPD diagnosis unless: a) they were a never smoker; OR b) former smoker with normal pulmonary function tests (PFT; FEV1/FVC ratio of \>70%); OR c) current smoker with normal PFTs within 24 months of enrollment; OR d) current or former smoker with obstruction on PFTs (FEV1/FVC ratio of \<70% but who demonstrates BOTH \>12% acute bronchodilator reversibility AND a normal diffusing capacity both within 24 months of enrollment (criteria successfully used in PREPARE);
- Use of single inhaler product that contains an ICS, LAMA and LABA or one containing both LABA and LAMA within 1 month of enrollment;
- Use of current biologic for less than 6 months;
- Known allergy to any of the components of the intervention;
- Coexisting lung disease (e.g. Cystic Fibrosis, connective tissue disease (unless asthma preceded diagnosis of connective tissue disease by at least 2 years), prematurity-born at 32 weeks or sooner, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis, among others)
- Has been in an asthma drug treatment trial in past 60 days or within 5 half-lives, whichever is longer, prior to study visit.
- Living in household with someone already enrolled in the study.
- Using daily or every other day oral corticosteroids for asthma or any other condition
- An AEX in the prior 4 weeks
- History of bronchial thermoplasty in prior 6 months
- Poorly or uncontrolled atrial fibrillation
- Not on stable asthma medications for at least 1 month prior to enrollment
- Using doses of ICS/LABA lower than the minimum below:
- Budesonide 320 ug,
- Fluticasone Advair Diskus/ Wixela 200-250 ug Advair HFA 180-230ug Airduo 110-113 ug Breo 100 ug
- Mometasone 200 ug
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
4100 Patients enrolled
Trial Details
Trial ID
NCT06596512
Start Date
November 1 2024
End Date
May 1 2030
Last Update
September 19 2024
Active Locations (6)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
3
Washington University
St Louis, Missouri, United States, 63110
4
Duke University
Durham, North Carolina, United States, 27705