Trial Outcomes & Findings for Trial of Roflumilast in Asthma Management (TRIM) (NCT NCT03532490)
NCT ID: NCT03532490
Last Updated: 2022-10-06
Results Overview
The Asthma Control Test was designed to help participants describe their asthma and how it affects how they feel and what they are able to do. They choose a response based on their asthma within the last 4 weeks. Participants select how many times per week they experience different asthma symptoms and how often they had to use a rescue inhaler or nebulizer. There are 5 questions with 5 responses; 1 meaning their asthma is not well controlled or they had symptoms more frequently, through 5 meaning they feel their asthma is well controlled or they do not experience any symptoms. The primary outcome is an unadjusted comparison of 24 week change in Asthma Control Test scores between the treatment groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2022-10-06
Participant Flow
Recruitment began in July 2018 and last participant visit was completed on July 2021. Participants were recruited from 7 clinical sites: University of Vermont, University of Arizona, Duke, University of Illinois, Chicago, Northwestern, University of Alabama, and Mount Sinai.
Participant milestones
| Measure |
Placebo Oral Tablet
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast 500 mcg Oral Tablet
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
22
|
|
Overall Study
COMPLETED
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Roflumilast in Asthma Management (TRIM)
Baseline characteristics by cohort
| Measure |
Placebo Oral Tablet
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast 500 mcg Oral Tablet
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
51 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Smoking status
Never
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Smoking status
Former
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age at asthma onset (years)
|
14 years
n=5 Participants
|
21 years
n=7 Participants
|
21 years
n=5 Participants
|
|
Asthma Control Test at Visit 2 (V2)
|
19 units on a scale
n=5 Participants
|
17 units on a scale
n=7 Participants
|
17 units on a scale
n=5 Participants
|
|
Asthma Symptom Utility Index
|
.8 units on a scale
n=5 Participants
|
.7 units on a scale
n=7 Participants
|
.7 units on a scale
n=5 Participants
|
|
Marks Asthma Quality of Life
|
2.1 units on a scale
n=5 Participants
|
1.8 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Patient Health Questionnaire-9
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
General Anxiety Disorder-7
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
0 units on a scale
n=5 Participants
|
|
Short form survey-36
|
59 units on a scale
n=5 Participants
|
67 units on a scale
n=7 Participants
|
62 units on a scale
n=5 Participants
|
|
Gastrointestinal Symptom Rating Scale
|
1.4 units on a scale
n=5 Participants
|
1.5 units on a scale
n=7 Participants
|
1.4 units on a scale
n=5 Participants
|
|
Forced expiratory volume at one second
|
1.91 liters
n=5 Participants
|
2.17 liters
n=7 Participants
|
2.03 liters
n=5 Participants
|
|
Forced Vital Capacity
|
3 liters
n=5 Participants
|
3.08 liters
n=7 Participants
|
3.08 liters
n=5 Participants
|
|
Forced Expiratory Volume/Forced vital capacity
|
.78 ratio
n=5 Participants
|
.76 ratio
n=7 Participants
|
.76 ratio
n=5 Participants
|
|
Methacholine PD20
|
115 microgram (mcg)
n=5 Participants
|
75 microgram (mcg)
n=7 Participants
|
95 microgram (mcg)
n=5 Participants
|
|
Greater than/equal to 1 unscheduled health visit for asthma in prior year
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Greater than/equal to 1 course of oral corticosteroids in prior year
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksThe Asthma Control Test was designed to help participants describe their asthma and how it affects how they feel and what they are able to do. They choose a response based on their asthma within the last 4 weeks. Participants select how many times per week they experience different asthma symptoms and how often they had to use a rescue inhaler or nebulizer. There are 5 questions with 5 responses; 1 meaning their asthma is not well controlled or they had symptoms more frequently, through 5 meaning they feel their asthma is well controlled or they do not experience any symptoms. The primary outcome is an unadjusted comparison of 24 week change in Asthma Control Test scores between the treatment groups.
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in Asthma Control Test Score
|
2 units on a scale
Interval 0.7 to 3.3
|
2.6 units on a scale
Interval 0.5 to 4.4
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksWeight change measured in kilograms (kg).
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in Weight
|
-1.7 kg
Interval -2.9 to -0.5
|
-2.2 kg
Interval -4.2 to -0.1
|
SECONDARY outcome
Timeframe: baseline and 24 weeksA 10-item questionnaire, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects, for use in clinical trials and cost-effectiveness studies in asthma. Range is 0-1. Higher score is indicative of better health.
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in Asthma Symptom Utility Index (ASUI)
|
.14 units on a scale
Interval 0.07 to 0.21
|
.16 units on a scale
Interval 0.09 to 0.23
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksIt has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores represent more discomfort and poor health.
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in Gastrointestinal Symptom Rating Scale (GSRS)
|
-.1 units on scale
Interval -0.4 to 0.2
|
0.0 units on scale
Interval -0.3 to 0.2
|
SECONDARY outcome
Timeframe: baseline and 24 weeksGAD-7 has 7 questions. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in Generalized Anxiety Disease (GAD-7)
|
0.0 units on scale
Interval -0.5 to 0.5
|
0.0 units on scale
Interval -0.8 to 0.6
|
SECONDARY outcome
Timeframe: baseline and 24 weeks20 items with 2 week recall. Self-administered questionnaire intended for use with adults. Respondents are asked to describe how troubling particular items have been over the past four weeks. Covers both physical and emotional impact. Range 1-4. lower score is indicative of better health
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in Marks Asthma Quality of Life Questionnaire
|
-.3 units on scale
Interval -0.6 to 0.0
|
-.4 units on scale
Interval -0.6 to -0.25
|
SECONDARY outcome
Timeframe: baseline and 24 weeksThe 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Range 0-100. Higher score is indicative of better health.
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in SF 36
|
6.4 units on scale
Interval 2.8 to 10.0
|
5.5 units on scale
Interval 2.5 to 8.6
|
SECONDARY outcome
Timeframe: baseline and 24 weeksThe PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. It has 9 questions. Range 0-27, lower score is indicate of better health.
Outcome measures
| Measure |
Placebo
n=16 Participants
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast
n=22 Participants
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day
|
|---|---|---|
|
Change in PHQ9
|
-.6 units on scale
Interval -1.6 to 0.5
|
0.0 units on scale
Interval -0.8 to 0.8
|
Adverse Events
Placebo Oral Tablet
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Roflumilast 500 mcg Oral Tablet
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Oral Tablet
n=16 participants at risk
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast 500 mcg Oral Tablet
n=22 participants at risk
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/16 • 24 weeks
|
13.6%
3/22 • Number of events 3 • 24 weeks
|
|
General disorders
Headache
|
0.00%
0/16 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
General disorders
Loss of appetite
|
0.00%
0/16 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
General disorders
Dehydration
|
0.00%
0/16 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain (umbilical hernia)
|
0.00%
0/16 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/16 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Placebo Oral Tablet
n=16 participants at risk
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
Roflumilast 500 mcg Oral Tablet
n=22 participants at risk
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/16 • 24 weeks
|
31.8%
7/22 • Number of events 7 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Congestion, runny nose, sneezing
|
12.5%
2/16 • Number of events 2 • 24 weeks
|
22.7%
5/22 • Number of events 5 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute upper respiratory tract infection
|
0.00%
0/16 • 24 weeks
|
13.6%
3/22 • Number of events 3 • 24 weeks
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/16 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
Cardiac disorders
chest pain
|
0.00%
0/16 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/16 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Acid reflux
|
0.00%
0/16 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • 24 weeks
|
4.5%
1/22 • Number of events 1 • 24 weeks
|
|
General disorders
Skin rash
|
6.2%
1/16 • Number of events 1 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle pain/aches
|
6.2%
1/16 • Number of events 1 • 24 weeks
|
9.1%
2/22 • Number of events 2 • 24 weeks
|
|
General disorders
Any emergent symptoms
|
25.0%
4/16 • Number of events 4 • 24 weeks
|
59.1%
13/22 • Number of events 13 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place