Trial Outcomes & Findings for Asthma Symptom Management Through Mindfulness Training (NCT NCT02275559)
NCT ID: NCT02275559
Last Updated: 2022-05-23
Results Overview
Asthma control will be assessed using the Asthma Control Questionnaire (ACQ). The ACQ is a 7-item validated measure that assesses the 5 asthma symptoms considered most important and most used by clinicians for evaluating asthma control, along with use of short-acting beta-agonist and FEV1 percent predicted. Patients recall their symptoms and short-acting beta-agonist use during the previous week; FEV1 is obtained from spirometry. All seven questions are scored on a 7-point scale (0=good control, 6=poor control), and the overall score (range 0-6) is the mean of the seven responses. Lower scores indicate better outcome. Minimum = 0, Maximum = 6. Changes of 0.5 or greater in the score are considered important differences.
COMPLETED
NA
233 participants
Baseline and 18 months
2022-05-23
Participant Flow
Participant milestones
| Measure |
Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
118
|
|
Overall Study
COMPLETED
|
115
|
118
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Asthma Symptom Management Through Mindfulness Training
Baseline characteristics by cohort
| Measure |
Mindfulness Based Stress Reduction
n=115 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=118 Participants
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.72 Years
STANDARD_DEVIATION 12.69 • n=5 Participants
|
51.96 Years
STANDARD_DEVIATION 14.75 • n=7 Participants
|
52.84 Years
STANDARD_DEVIATION 13.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
118 participants
n=7 Participants
|
233 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18 monthsAsthma control will be assessed using the Asthma Control Questionnaire (ACQ). The ACQ is a 7-item validated measure that assesses the 5 asthma symptoms considered most important and most used by clinicians for evaluating asthma control, along with use of short-acting beta-agonist and FEV1 percent predicted. Patients recall their symptoms and short-acting beta-agonist use during the previous week; FEV1 is obtained from spirometry. All seven questions are scored on a 7-point scale (0=good control, 6=poor control), and the overall score (range 0-6) is the mean of the seven responses. Lower scores indicate better outcome. Minimum = 0, Maximum = 6. Changes of 0.5 or greater in the score are considered important differences.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=101 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=106 Participants
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Change From Baseline in Asthma Control at 18 Months
|
1.27 score on a scale
Standard Error 0.11
|
1.17 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsAsthma-related quality of life will be assessed using the Asthma-related QoL (AQoL) measure.The AQoL has 30 items assessing impairment in 4 areas of function shown to be important to the QoL of adult patients with asthma (activity limitations, asthma symptoms, emotional function and environmental exposure). Overall QoL is computed by averaging scores on the 4 domains. Items assess the degree to which important activities have been limited by asthma during the last 2 weeks on a 7-point scale (1= maximal impairment, 7= no impairment). Shown to be valid, reliable and sufficiently sensitive to changes in asthma symptoms to capture the effects of an intervention in a clinical trial. Higher scores = better outcome, minimum score = 30, maximum score 210. Changes in scores of 0.5 or above represent clinically meaningful improvement in QoL.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=99 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=106 Participants
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Change From Baseline in Asthma-related Quality of Life at 18 Months
|
5.19 score on a scale
Standard Error 0.13
|
5.29 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and 18-monthsRespiratory interoceptive accuracy will be measured using the Breath Perception Discrimination Test (BPDT). The BPDT measures ability to detect small changes in resistive load. This test will be done in the Pulmonary Diagnostic Laboratory at each site. During the test period, the presentation of the resistor will be announced at the onset of a new inspiration for the duration of one full breath cycle. At the conclusion of the breath cycle, participants pause for 5 normal breaths, at which point the next resistor in the block is presented. The test will be divided into 6 blocks during which there is a random presentation of each resistor so that participants carry out 30 ratings (6 for each condition) over the course of the test. Higher score is better outcome, lower score is worse outcome. Lowest score is zero percent, highest score is 100% Time to complete: 30 minutes.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=68 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=73 Participants
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Change From Baseline in Respiratory Interoceptive Accuracy at 18-months
|
0.79 score on a scale
Standard Error 0.01
|
0.77 score on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline and 18-monthsPopulation: This combination of the two arms was the prespecified analysis.
Lung function will be assessed via spirometry. Spirometry assesses the level of air flow limitation according to the forced expiratory volume in 1 second (FEV1). The unit of measure is not a score on a scale but rather "percent predicted expiratory volume" to assess air flow limitation. Measurement will be done in the site Pulmonary Diagnostic Laboratories according to American Thoracic Society guidelines before and after inhalation of bronchodilator. This includes instructing participants to not take a bronchodilator at least 4 hours prior to their spirometry, and assessing lung function both before, and then 30 minutes after bronchodilator to assess best lung function and responsiveness to bronchodilator therapy. Higher scores mean better outcome.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=71 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=65 Participants
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Change From Baseline in Percent Predicted Expiratory Volume at 18-months.
|
360.89 percent predicted expiratory volume
Standard Error 8.92
|
351.8 percent predicted expiratory volume
Standard Error 12.07
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: This combination of the two arms was the prespecified analysis.
This outcome is the Incremental Cost Effectiveness Ratio (ICER). The ICER estimates how much the MBSR intervention costs, relative to the HLC intervention, to improve the outcome measure by 1 unit. The ICER is calculated by dividing the incremental cost by the incremental outcome. The Incremental cost is difference in total costs (sum of program costs and healthcare costs over 18 months, in U.S. dollars) between the MBSR and HLC groups. The Incremental outcome is the difference between the groups in the chosen measure of health outcome at 18 months (here, mean Asthma-related QoL (AQoL) questionnaire scores).
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=233 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Cost Per Change in Quality of Life (QOL)
|
10,006 U.S. Dollars/1 point of QOL improvement
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: This combination of the two arms was the prespecified analysis.
This outcome is the Incremental Cost Effectiveness Ratio (ICER). The ICER estimates how much the MBSR intervention costs, relative to the HL intervention, to improve the outcome measure by 1 unit. The ICER is calculated by dividing the incremental cost by the incremental outcome. The incremental cost is the difference in total costs (sum of program costs and healthcare costs over 18 months, in U.S. dollars) between the MBSR and HLC groups. The incremental outcome is the difference between the groups at 18 months in the chosen measure of health outcome (here, mean Predicted FEV1 scores). This is not a scale.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=233 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Cost in Change of Percent Predicted FEV
|
145 US. Dollars/1 point % Predicted FEV
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: This combination of the two arms was the prespecified analysis.
This outcome is the Incremental Cost Effectiveness Ratio (ICER). The ICER estimates how much the MBSR intervention costs, relative to the HL intervention, to improve the outcome measure by 1 unit. The ICER is calculated by dividing the Incremental cost by the incremental outcome. The incremental cost is the difference in total costs (sum of program costs and healthcare costs over 18 months, in U.S. dollars) between the MBSR and HLC groups. The incremental outcome is the difference between the groups in the chosen measure of health outcome 18 months (here, mean Asthma Control Score). This is not a scale.
Outcome measures
| Measure |
Mindfulness Based Stress Reduction
n=233 Participants
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Cost in Change of Asthma Control
|
3,255 US $/1 point of Change of Asthma Control
|
—
|
Adverse Events
Mindfulness Based Stress Reduction
Healthy Living Course (HLC)
Serious adverse events
| Measure |
Mindfulness Based Stress Reduction
n=115 participants at risk
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=118 participants at risk
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Surgical and medical procedures
Appendectomy
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral lower extremity pain with weakness
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Psychiatric disorders
Inpatient hospitalization with subsequent adult partial program admission
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Cardiac disorders
Chest congestion associated with l sided arm weakness and lower extremity weakness & numbness
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Surgical and medical procedures
Surgical repair of lumbar spondylosis with radiculopathy
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Surgical and medical procedures
Gastric bypass
|
3.5%
4/115 • Number of events 4 • 18 months
|
0.00%
0/118 • 18 months
|
|
Surgical and medical procedures
Kidney Removal
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Surgical and medical procedures
Hysterectomy
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Blood and lymphatic system disorders
Microcytic anemia with iron deficiency, secondary to gi blood loss in the setting of nsaid use
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.87%
1/115 • Number of events 1 • 18 months
|
5.9%
7/118 • Number of events 7 • 18 months
|
|
Surgical and medical procedures
Thyroid Gland Surgery
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Metabolism and nutrition disorders
Dysphagia & dehydration
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysematous pyelonephritis
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia due to infectious organism
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Broken hip
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Surgery; L4/5 discectomy
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Peritoneal abscess
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Psychiatric disorders
Recurrent major depressive episode
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Infections and infestations
Drug-induced, allergic reaction to Bactrim
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Arthritis spinal stenosis and spondylolisthesis surgery
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Surgery to repair small bowel obstruction
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Hernia Surgery
|
0.87%
1/115 • Number of events 1 • 18 months
|
0.00%
0/118 • 18 months
|
|
Surgical and medical procedures
Abdominal myomectomy
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Cardiac disorders
Chest pain & syncope
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Nervous system disorders
Slurred speech ruled out TIA
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Patient fell
|
0.00%
0/115 • 18 months
|
0.85%
1/118 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
Mindfulness Based Stress Reduction
n=115 participants at risk
Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
Mindfulness Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
|
Healthy Living Course (HLC)
n=118 participants at risk
The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
Healthy Living Course (HLC): The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Clinically significant decrease of ≥ 15% in spirometry from baseline in FEV1.
|
8.7%
10/115 • Number of events 11 • 18 months
|
8.5%
10/118 • Number of events 13 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place