AsthmaASP RCTNCT06612294
Asthma Symptom Perception Study
A study testing PEF Interventional Session and Active booster in people with Asthma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
Asthma affects 8% of the United States population ages >60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- PEF Interventional Session and Active booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2024to 22 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 years
- English or Spanish speaking
- Self-report or physician diagnosis of asthma >1 year ago
- Uncontrolled asthma
Who cannot join
- Dementia
- Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses,
- Congestive Heart Failure (CHF, New York Heart Association [NYHA] stages 4-5)
- Cigarette smoking >15 packs-years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ichan School of Medicine at Mount Sinai
New York, New York, 10029
Dhanya Chanumolu, MPH, 332-777-5754, dhanya.chanumolu@mountsinai.org
Juan Winsnivesky
- Not yet recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
Juliana Rodriguez, (718)-862-1722, juliana.rodriguez@einsteinmed.edu
Jonathan Feldman
About this study
Official title: A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma
Asthma affects 8% of the United States population ages >60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perception of expiratory airflow limitation may be a major determinant of asthma outcomes in older adults, and that older adults are substantially less aware of airway obstruction than younger adults. These observations suggest that perception of airflow limitation is a potential target for improving outcomes of older patients with asthma. The research team completed a pilot randomized controlled trial (RCT) of an intervention that trains older adults with asthma to better perceive expiratory airway obstruction through feedback via peak expiratory flow (PEF) prediction and couples this feedback with motivational interviewing (MI) to promote change in asthma self-management behaviors. Compared to an attention control, the intervention improved PEF, perception of airflow limitation and asthma control. In this project, the research team will conduct a fully powered RCT to test the intervention's efficacy among 300 adults ages ≥60 years with uncontrolled asthma who are on controller medications (daily maintenance or as needed) recruited from underserved inner-city medical practices in New York City. Patients will be randomized to the intervention or a time and attention matched educational control. The intervention and control will be delivered in 3 sessions over 6 weeks. The study will test the impact of the intervention on perception of expiratory airflow limitation in older adults with asthma, examine the efficacy of the intervention for improvements in lung function (PEF), self-reported asthma control (Asthma Control Questionnaire [ACQ] scores), quality of life (Asthma Quality of Life Questionnaire [AQLQ] scores), and emergency department and hospital use, and test the intervention's impact on mean daily ICS dose used (daily maintenance and as needed). Data will be collected at baseline, 1-month, 6-months (primary analyses of effectiveness) and 12-months post-intervention. In secondary analyses, the research team will test the sustainability of treatment effects with vs. without the booster treatment session (active booster vs. attention control booster) delivered immediately after the 6-month assessment on outcomes at 12-months.
- Conditions
- Asthma
- Being tested
- PEF Interventional Session, Control Sessions, Control Booster, Active booster
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEF Interventional SessionBehavioural
3 sessions over 6 weeks for asthma management
Control SessionsBehavioural
3 sessions over 6 weeks for asthma management
Control BoosterBehavioural
A single booster session after the 6-months assessments are completed.
Active boosterBehavioural
A single booster session after the 6-months assessments are completed.
| Study group | Role | What they receive |
|---|---|---|
| PEF group with active booster | Experimental | This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point. Receives: Behavioral: PEF Interventional Session; Behavioral: Active booster |
| PEF group with control booster | Experimental | This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point. Receives: Behavioral: PEF Interventional Session; Behavioral: Control Booster |
| Control Group | Placebo comparator | This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point. Receives: Behavioral: Control Sessions; Behavioral: Control Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow (PEF) Values
Perception accuracy of airflow limitation will be measured by perceived and actual PEF values.
Measured: at baseline, 1-month, 6-months, and 12-months post-intervention
Mean daily ICS dose used
Mean daily ICS dose will be recorded for asthma medications
Measured: at baseline, 1-month, 6-months, and 12-months post-intervention
Secondary outcomes (4)
Number of participants using medications on ≥70% of days prescribed
Adherence will be measured via the number of participants using medications on ≥70% of days prescribed.
Measured: at baseline, 1-month, 6-months, and 12-months post-intervention
Participant personal best PEF percent
Participant personal best PEF percent will be collected using the AM2 during assessments of perception of airflow limitation.
Measured: at baseline, 1-month, 6-months, and 12-months post-intervention
Asthma Control Questionnaire [ACQ] scores
The ACQ is a self-reported questionnaire that assess asthma beliefs about asthma control. The ACQ is an instrument, full scale from 0-6, higher score indicates more impairment.
Measured: at baseline, 1-month, 6-months, and 12-months post-intervention
Asthma Quality of Life Questionnaire [AQLQ] scores
The AQLQ assess asthma beliefs about asthma quality of life. The AQLQ is an instrument, full scale from 1-7, higher score indicates better health outcomes.
Measured: at baseline, 1-month, 6-months, and 12-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start18 Sep 2024
- Primary completion22 Dec 2028 (estimated)
- Study completion22 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Yeshiva University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Juan Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Wisnivesky, MD, DrPH, Principal investigator, Division Chief, General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612294
- Sponsor's protocol ID
- GCO 23-0259
- Other IDs
- 1R01HL171676-01
- Acronym
- ASP RCT
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma
- ClinicalTrials.gov ID
- NCT06612294
- Acronym / sponsor ID
- ASP RCT / GCO 23-0259
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Yeshiva University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 22 Dec 2028 (estimated)
- Study completion
- 22 Dec 2028 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma affects 8% of the United States population ages >60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perception of expiratory airflow limitation may be a major determinant of asthma outcomes in older adults, and that older adults are substantially less aware of airway obstruction than younger adults. These observations suggest that perception of airflow limitation is a potential target for improving outcomes of older patients with asthma. The research team completed a pilot randomized controlled trial (RCT) of an intervention that trains older adults with asthma to better perceive expiratory airway obstruction through feedback via peak expiratory flow (PEF) prediction and couples this feedback with motivational interviewing (MI) to promote change in asthma self-management behaviors. Compared to an attention control, the intervention improved PEF, perception of airflow limitation and asthma control. In this project, the research team will conduct a fully powered RCT to test the intervention's efficacy among 300 adults ages ≥60 years with uncontrolled asthma who are on controller medications (daily maintenance or as needed) recruited from underserved inner-city medical practices in New York City. Patients will be randomized to the intervention or a time and attention matched educational control. The intervention and control will be delivered in 3 sessions over 6 weeks. The study will test the impact of the intervention on perception of expiratory airflow limitation in older adults with asthma, examine the efficacy of the intervention for improvements in lung function (PEF), self-reported asthma control (Asthma Control Questionnaire [ACQ] scores), quality of life (Asthma Quality of Life Questionnaire [AQLQ] scores), and emergency department and hospital use, and test the intervention's impact on mean daily ICS dose used (daily maintenance and as needed). Data will be collected at baseline, 1-month, 6-months (primary analyses of effectiveness) and 12-months post-intervention. In secondary analyses, the research team will test the sustainability of treatment effects with vs. without the booster treatment session (active booster vs. attention control booster) delivered immediately after the 6-month assessment on outcomes at 12-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEF group with active booster | Experimental | Behavioral: PEF Interventional Session, Behavioral: Active boosterThis arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point. |
| PEF group with control booster | Experimental | Behavioral: PEF Interventional Session, Behavioral: Control BoosterThis arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point. |
| Control Group | Placebo comparator | Behavioral: Control Sessions, Behavioral: Control BoosterThis arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 60 years
- English or Spanish speaking
- Self-report or physician diagnosis of asthma >1 year ago
- Uncontrolled asthma
Key exclusion criteria (4 listed)
- Dementia
- Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses,
- Congestive Heart Failure (CHF, New York Heart Association [NYHA] stages 4-5)
- Cigarette smoking >15 packs-years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEF Interventional Session3 sessions over 6 weeks for asthma management | Behavioural | PEF group with active booster, PEF group with control booster |
| Control Sessions3 sessions over 6 weeks for asthma management | Behavioural | Control Group |
| Control BoosterA single booster session after the 6-months assessments are completed. | Behavioural | Control Group, PEF group with control booster |
| Active boosterA single booster session after the 6-months assessments are completed. | Behavioural | PEF group with active booster |
Primary outcome
Peak expiratory flow (PEF) Values
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Perception accuracy of airflow limitation will be measured by perceived and actual PEF values.
Mean daily ICS dose used
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Mean daily ICS dose will be recorded for asthma medications
4 secondary outcomes
Number of participants using medications on ≥70% of days prescribed
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Participant personal best PEF percent
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Asthma Control Questionnaire [ACQ] scores
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Asthma Quality of Life Questionnaire [AQLQ] scores
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Asthma
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Wisnivesky, MD, DrPH principal investigator
Division Chief, General Internal Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEF Interventional Session and Active booster in people with Asthma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Wisnivesky, MD, DrPH (212-824-7845, juan.wisnivesky@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak expiratory flow (PEF) Values (time frame: at baseline, 1-month, 6-months, and 12-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.