Trial Outcomes & Findings for The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial (NCT NCT00156819)
NCT ID: NCT00156819
Last Updated: 2015-12-09
Results Overview
The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
16 weeks
Results posted on
2015-12-09
Participant Flow
Participant milestones
| Measure |
Fluticasone
Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Montelukast
Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Fluticasone Plus Salmeterol
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
|---|---|---|---|
|
Overall Study
STARTED
|
169
|
166
|
165
|
|
Overall Study
COMPLETED
|
168
|
165
|
162
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Fluticasone
Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Montelukast
Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Fluticasone Plus Salmeterol
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
Baseline Characteristics
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Baseline characteristics by cohort
| Measure |
Fluticasone
n=169 Participants
Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Montelukast
n=166 Participants
Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Fluticasone Plus Salmeterol
n=165 Participants
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.
Outcome measures
| Measure |
Fluticasone
n=168 Participants
Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Montelukast
n=165 Participants
Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Fluticasone Plus Salmeterol
n=162 Participants
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
|---|---|---|---|
|
Treatment Failure
|
34 participants
|
50 participants
|
33 participants
|
Adverse Events
Fluticasone
Serious events: 6 serious events
Other events: 159 other events
Deaths: 0 deaths
Montelukast
Serious events: 4 serious events
Other events: 156 other events
Deaths: 0 deaths
Fluticasone Plus Salmeterol
Serious events: 4 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluticasone
n=168 participants at risk
Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Montelukast
n=165 participants at risk
Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Fluticasone Plus Salmeterol
n=162 participants at risk
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.60%
1/168
|
0.00%
0/165
|
0.00%
0/162
|
|
Cardiac disorders
Chest pain
|
0.60%
1/168
|
0.00%
0/165
|
0.00%
0/162
|
|
Surgical and medical procedures
Partial right knee replacement surgery
|
0.60%
1/168
|
0.00%
0/165
|
0.00%
0/162
|
|
Respiratory, thoracic and mediastinal disorders
Drop in peak flow
|
0.60%
1/168
|
0.61%
1/165
|
0.00%
0/162
|
|
Injury, poisoning and procedural complications
Anaphylactic reaction to peanuts
|
0.60%
1/168
|
0.00%
0/165
|
0.00%
0/162
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.60%
1/168
|
0.61%
1/165
|
0.00%
0/162
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/168
|
0.00%
0/165
|
0.62%
1/162
|
|
Psychiatric disorders
Depression
|
0.00%
0/168
|
0.00%
0/165
|
0.62%
1/162
|
|
Injury, poisoning and procedural complications
Allergic reaction to Bactim
|
0.00%
0/168
|
0.00%
0/165
|
0.62%
1/162
|
|
Injury, poisoning and procedural complications
Elbow sprain
|
0.00%
0/168
|
0.00%
0/165
|
0.62%
1/162
|
|
Injury, poisoning and procedural complications
Abcess
|
0.00%
0/168
|
0.61%
1/165
|
0.00%
0/162
|
|
Surgical and medical procedures
Tonsilectomy
|
0.00%
0/168
|
0.61%
1/165
|
0.00%
0/162
|
Other adverse events
| Measure |
Fluticasone
n=168 participants at risk
Participants continued fluticasone (100 microgram twice daily) treatment.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Montelukast
n=165 participants at risk
Participants were changed to Montelukast (5 or 10 mg each night).
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
Fluticasone Plus Salmeterol
n=162 participants at risk
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
fluticasone: fluticasone (100 microgram twice daily) treatment
montelukast: Montelukast (5 or 10 mg each night).
Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
37.5%
63/168
|
26.7%
44/165
|
38.3%
62/162
|
|
Infections and infestations
Pharyngitis
|
49.4%
83/168
|
49.7%
82/165
|
48.1%
78/162
|
|
Infections and infestations
Rhinitis
|
71.4%
120/168
|
67.3%
111/165
|
72.8%
118/162
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory inflammation
|
50.0%
84/168
|
40.6%
67/165
|
45.1%
73/162
|
|
General disorders
Hoarsness/ dysphonia
|
54.8%
92/168
|
47.3%
78/165
|
53.7%
87/162
|
|
Infections and infestations
Sinisitis
|
39.9%
67/168
|
30.9%
51/165
|
30.9%
50/162
|
|
General disorders
Nasal congestion
|
81.0%
136/168
|
77.0%
127/165
|
79.6%
129/162
|
|
Infections and infestations
Viral respiratory infection
|
15.5%
26/168
|
7.3%
12/165
|
13.6%
22/162
|
|
Infections and infestations
Influenza
|
8.9%
15/168
|
4.8%
8/165
|
9.9%
16/162
|
|
General disorders
Headache
|
71.4%
120/168
|
70.9%
117/165
|
69.1%
112/162
|
|
General disorders
Diarrhea
|
24.4%
41/168
|
21.2%
35/165
|
19.1%
31/162
|
|
Gastrointestinal disorders
Nausea and vomitting
|
32.7%
55/168
|
21.2%
35/165
|
22.8%
37/162
|
|
Gastrointestinal disorders
Gastrointestinal distress
|
37.5%
63/168
|
34.5%
57/165
|
37.7%
61/162
|
|
Infections and infestations
Fever
|
26.8%
45/168
|
15.2%
25/165
|
22.2%
36/162
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
37.5%
63/168
|
43.0%
71/165
|
43.2%
70/162
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place