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Improving the Quality of Care for Asthma Patients at Risk of Exacerbations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to use asthma inhalers to prevent flare-ups: MART and PARTICS. MART uses one combined inhaler for daily care and quick relief; PARTICS adds a steroid inhaler each time rescue medicine is used. It is for adults ages 18–75 with moderate-to-severe asthma who use a daily combined inhaler and have had a serious flare-up in the past year.

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 medications. This strategy is known as MART (maintenance and reliever therapy). The second strategy is PARTICS (patient activated reliever triggered ICS) strategy instructs patients to use an ICS metered dose inhaler (ICS) each time they use their rescue inhaler. In addition, they are instructed to take 5 puffs of the ICS after each rescue nebulizer use. PARTICS has been shown to reduce exacerbations, increase asthma control and quality of life, however, the question remains if PARTICS is as effective as MART and therefore be an alternative to MART. This trial will test PARTICS and MART head-to-head. The trial will include adults with moderate-to-severe asthma at risk for an asthma exacerbation, currently using a combination ICS. The main questions aim to answer: * Is PARTICS as effective as SMART? * Might PARTICS be more effective than SMART? Is the relative effectiveness of PARTICS versus SMART affected by frequent nebulizer use for asthma relief? * Do PARTICS and SMART diverge in terms of their effectiveness on differing asthma outcomes important to patients? * Do socioeconomic factors affect the relative effectiveness of PARTICS and SMART? Researchers will compare non frequent nebulizer (NFN) users - less than once a week to frequent nebulizer users - once a week or more, to assess whether the PARTICS strategy is ono-inferior (or superior to the MART strategy in reducing exacerbations, (primary outcome), increasing asthma control and quality of life and decrease days lost from work/school or usual activities. Most participants will be consented, enrolled, and randomized virtually, others will be consented, enrolled and randomized in person. Once randomized they will be instructed on how to use the prescribed medication: * Participants randomized to MART will be instructed to use the prescribed ICS/LABA for maintenance and as needed for rescue. * Participants randomized to PARTICS will be instructed to use the prescribed ICS each time they use their rescue inhaler and take 5 puffs of the newly prescribed ICS after each rescue nebulizer use. * Participants will be followed for 16 months by monthly survey.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–75 years old and have asthma diagnosed by a clinician at least 1 year ago.
  • Have had at least one serious asthma flare-up in the past 12 months. It must have required steroid pills or shots for at least 72 hours, or a hospital stay longer than 24 hours.
  • If using a biologic medicine for asthma, have had the flare-up after at least 6 months on that treatment.
  • Have been prescribed a daily ICS/LABA inhaler for at least 1 month at the study’s minimum dose. This combines a steroid to reduce swelling with a long-acting medicine to open airways.
  • Have a short-acting rescue inhaler and use it at least once a month on average.
  • Be able to give consent in English for the early feasibility study, or in English or Spanish for the full study.

Who can't join

  • Expected to live less than 2 years, or have poorly controlled atrial fibrillation, an irregular heartbeat.
  • Have COPD, a long-term lung disease, unless you meet the study’s smoking-history or breathing-test exceptions.
  • Have another listed lung condition, an organ transplant, or a history of birth at 32 weeks or earlier. Connective tissue disease is excluded unless asthma started at least 2 years before it.
  • Have used an ICS/LAMA/LABA or LABA/LAMA combined inhaler in the past month, used your current biologic medicine for less than 6 months, or have an allergy to a study medicine ingredient.
  • Take steroid pills daily or every other day, have changed asthma medicines in the past month, or use an ICS/LABA dose below the study’s minimum.
  • Have had an asthma flare-up in the past 4 weeks, or bronchial thermoplasty—a procedure that treats the airways—in the past 6 months.
  • Have been in an asthma drug trial within the past 60 days, or longer if needed for five drug half-lives—the time it takes the body to clear most of the drug.
  • Live with someone already enrolled in this study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (6)

CT

MA

MO

NC

PA

WI