Trial Outcomes & Findings for A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial (NCT NCT01696214)
NCT ID: NCT01696214
Last Updated: 2019-01-23
Results Overview
The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score \<16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
Results posted on
2019-01-23
Participant Flow
Participant milestones
| Measure |
Ipratropium
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times
|
Theophylline
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks
|
Montelukast
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ipratropium
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times
|
Theophylline
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks
|
Montelukast
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial
Baseline characteristics by cohort
| Measure |
Ipratropium
n=4 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times
|
Theophylline
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.
Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks
|
Montelukast
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
n=5 Participants
Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
48 years
n=7 Participants
|
39 years
n=5 Participants
|
28 years
n=4 Participants
|
41 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
19 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score \<16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.
Outcome measures
| Measure |
Ipratropium
n=4 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.
ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
|
Theophylline
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.
Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks
|
Montelukast
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.
Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
n=5 Participants
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
|
|---|---|---|---|---|
|
Asthma Control Test
|
17.5 units on a scale
Interval 13.0 to 19.0
|
13 units on a scale
Interval 7.0 to 19.0
|
12 units on a scale
Interval 9.0 to 15.0
|
10 units on a scale
Interval 5.0 to 13.0
|
SECONDARY outcome
Timeframe: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were comparedThe Asthma Symptom Utility Index (ASUI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics. ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. 11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity). 4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe). Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The change between two time points, initial visit and after 24 weeks of treatment, is reported. The median value is reported with the standard deviation.
Outcome measures
| Measure |
Ipratropium
n=4 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.
ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
|
Theophylline
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.
Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks
|
Montelukast
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.
Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
n=5 Participants
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
|
|---|---|---|---|---|
|
The Asthma Symptom Utility Index (ASUI)
|
0.16 units on a scale
Standard Deviation 0.07
|
0.24 units on a scale
Standard Deviation 0.20
|
0.14 units on a scale
Standard Deviation 0.15
|
0.13 units on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were comparedPhysiologic measures of % predicted FEV1
Outcome measures
| Measure |
Ipratropium
n=4 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.
ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
|
Theophylline
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.
Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks
|
Montelukast
n=5 Participants
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.
Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
n=5 Participants
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
|
|---|---|---|---|---|
|
Percent (%) Perdicted FEV1 Changes
|
-1.62 percent predicted FEV1
Standard Deviation 7.89
|
4.73 percent predicted FEV1
Standard Deviation 7.72
|
0.87 percent predicted FEV1
Standard Deviation 10.57
|
-5.71 percent predicted FEV1
Standard Deviation 5.24
|
Adverse Events
Ipratropium
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Theophylline
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Montelukast
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Fluticasone 250 mg/Salmeterol 50mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ipratropium
n=5 participants at risk；n=4 participants at risk
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times
|
Theophylline
n=5 participants at risk
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.
Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks
|
Montelukast
n=5 participants at risk
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
n=5 participants at risk
Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
0.00%
0/4 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
Social circumstances
death
|
0.00%
0/4 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
Other adverse events
| Measure |
Ipratropium
n=5 participants at risk；n=4 participants at risk
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.
Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times
|
Theophylline
n=5 participants at risk
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.
Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks
|
Montelukast
n=5 participants at risk
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.
Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks.
|
Fluticasone 250 mg/Salmeterol 50mg
n=5 participants at risk
Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.
Fluticasone 250 mg/salmeterol 50 mg:
Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50
|
|---|---|---|---|---|
|
Nervous system disorders
migraine headache
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Infections and infestations
viral infection
|
80.0%
4/5 • Number of events 4 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
60.0%
3/5 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
20.0%
1/5 • Number of events 2 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
drowsiness
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Social circumstances
motor vehicle accident
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
General disorders
dry mouth
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
urinary tract infection
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Cardiac disorders
tachycardia
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
headache
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
General disorders
edema
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin lesion
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
swollen hand
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
sprained finger
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
|
Eye disorders
iritis
|
0.00%
0/5 • 1 year
|
0.00%
0/5 • 1 year
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place