Trial · NCT02995733
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
NCT02995733, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2023-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief. Trials, record NCT02995733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02995733
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
- NCT number
- NCT02995733
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,220 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Asthma
- Interventions
- PARTICS using QVAR
- First posted
- 2016-12-16
- Last updated
- 2023-01-19
- Results first posted
- 2023-01-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Asthma Exacerbations Per Year | monthly through study completion an average of 15 months | Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year |
| Secondary | Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline | Monthly through study completion an average of 15 months | 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 minimal clinically important difference is 3 points |
| Secondary | Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline | Monthly through study completion an average of 15 months | The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09. |
| Secondary | Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma | Monthly through study completion an average of 15 months | Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Asthma Exacerbations Per Year | monthly through study completion an average of 15 months | Adjusted annualized exacerbations | MEAN | |
| SECONDARY | Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline | Monthly through study completion an average of 15 months | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline | Monthly through study completion an average of 15 months | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma | Monthly through study completion an average of 15 months | days per year | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Asthma Exacerbations Per Year | PARTICS | 0.69 | 95% Confidence Interval 0.61 to 0.78 | Adjusted annualized exacerbations | |
| Rate of Asthma Exacerbations Per Year | Usual Care | 0.82 | 95% Confidence Interval 0.73 to 0.92 | Adjusted annualized exacerbations | |
| Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline | PARTICS | 3.4 | 95% Confidence Interval 3.1 to 3.6 | units on a scale | |
| Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline | Usual Care | 2.5 | 95% Confidence Interval 2.3 to 2.8 | units on a scale | |
| Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline | PARTICS | 0.12 | 95% Confidence Interval 0.11 to 0.13 | units on a scale | |
| Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline | Usual Care | 0.08 | 95% Confidence Interval 0.07 to 0.09 | units on a scale | |
| Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma | PARTICS | 13.4 | 95% Confidence Interval 11.9 to 15.2 | days per year | |
| Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma | Usual Care | 16.8 | 95% Confidence Interval 14.9 to 18.9 | days per year |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PARTICS | 609 | |
| Overall Study | STARTED | Usual Care | 611 | |
| Overall Study | COMPLETED | PARTICS | 542 | |
| Overall Study | COMPLETED | Usual Care | 557 | |
| Overall Study | NOT COMPLETED | PARTICS | 67 | |
| Overall Study | NOT COMPLETED | Usual Care | 54 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | PARTICS | 43 | 609 | 68 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Usual Care | 45 | 611 | 85 |
| serious | Cardiac events | Cardiac disorders | PARTICS | 8 | 609 | 9 |
| serious | Cardiac events | Cardiac disorders | Usual Care | 10 | 611 | 10 |
| serious | Gastrointestinal disorders | Gastrointestinal disorders | PARTICS | 6 | 609 | 6 |
| serious | Gastrointestinal disorders | Gastrointestinal disorders | Usual Care | 4 | 611 | 4 |
| serious | Hematology/oncology | Blood and lymphatic system disorders | PARTICS | 0 | 609 | 0 |
| serious | Hematology/oncology | Blood and lymphatic system disorders | Usual Care | 4 | 611 | 11 |
| serious | Immune system disorders | Immune system disorders | PARTICS | 1 | 609 | 1 |
| serious | Immune system disorders | Immune system disorders | Usual Care | 2 | 611 | 2 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PARTICS | 3 | 609 |
| Total, all-cause mortality | Usual Care | 4 | 611 |
| Total, other adverse events | PARTICS | 0 | 609 |
| Total, other adverse events | Usual Care | 0 | 611 |
| Total, serious adverse events | PARTICS | 75 | 609 |
| Total, serious adverse events | Usual Care | 74 | 611 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PARTICS vs Usual Care: deaths from any cause | Trial comparisons |
| PARTICS vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02995733
GET https://conductscience.org/api/trials/v1/NCT02995733/events?page=2