N/A
Completed N=233
Asthma Symptom Management Through Mindfulness Training
Source: ClinicalTrials.gov NCT02275559 ↗Enrolled (actual)
233
Serious AEs
12.9%
Results posted
May 2022
Primary outcomePrimary: Change From Baseline in Asthma Control at 18 Months — 1.27; 1.17 score on a scale
Summary
Asthma is one of the four most common adult chronic disorders. Supporting asthma patients in improving their asthma control and symptoms as well as their quality of life are important goals in clinical management. This study will test the effect of a widely-available mindfulness training program in improving asthma control and symptoms and quality of life among patients with asthma, and explore the relationship between asthma control and a number of factors, including how well patients perceive their respiratory symptoms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Asthma Control at 18 Months |
1.27; 1.17 | — |
| SECONDARY Change From Baseline in Asthma-related Quality of Life at 18 Months |
5.19; 5.29 | — |
| SECONDARY Change From Baseline in Respiratory Interoceptive Accuracy at 18-months |
0.79; 0.77 | — |
| SECONDARY Change From Baseline in Percent Predicted Expiratory Volume at 18-months. |
360.89; 351.8 | — |
| SECONDARY Cost Per Change in Quality of Life (QOL) |
10,006 | — |
| SECONDARY Cost in Change of Percent Predicted FEV |
145 | — |
| SECONDARY Cost in Change of Asthma Control |
3,255 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 and older
- Documented diagnosis of asthma from a physician for greater than 12 months that includes an objective indicator of bronchial hyperresponsiveness (positive methacholine challenge test or > 12% improvement in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) in response to bronchodilator);
- Meets criteria for mild, moderate or severe asthma
- Treatment with inhaled corticosteroids for at least 12 weeks with stable dosing for greater than 4 weeks;
- Able to read and understand English, and complete informed consent process and study data collection procedures.
Exclusion Criteria
- Current smoker or greater than 10 pack-year smoking history
- Diagnosis of asthma of intermittent severity
- Other lung diseases besides asthma
- Cancer, except non-melanoma skin cancer;
- Currently receiving treatment for symptomatic cardiovascular disease within past 6 months
- Current or recent (within the past 3 months) severe exacerbation of asthma requiring hospitalization or oral glucocorticoids;
- Currently pregnant
- Major psychiatric disorders or psychiatric hospitalization in the last 2 years;
- Has taken the MBSR program in the past, and/or currently practicing meditation or yoga on a regular basis.
Data sourced from ClinicalTrials.gov (NCT02275559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.