Trial Outcomes & Findings for Study of Asthma and Nasal Steroids (NCT NCT01118312)
NCT ID: NCT01118312
Last Updated: 2015-11-30
Results Overview
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
388 participants
Primary outcome timeframe
24 weeks
Results posted on
2015-11-30
Participant Flow
Participant milestones
| Measure |
Nasal Steroid
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
199
|
|
Overall Study
COMPLETED
|
155
|
164
|
|
Overall Study
NOT COMPLETED
|
34
|
35
|
Reasons for withdrawal
| Measure |
Nasal Steroid
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
33
|
32
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Study of Asthma and Nasal Steroids
Baseline characteristics by cohort
| Measure |
Nasal Steroid
n=189 Participants
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
n=199 Participants
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
72 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
117 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Analysis of adult (18 and above) Asthma Control Scores
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Outcome measures
| Measure |
Nasal Steroid
n=117 Participants
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
n=120 Participants
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
|---|---|---|
|
Asthma Control Test (ACT)
|
2.95 units on a scale
Standard Error 0.31
|
2.44 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
Outcome measures
| Measure |
Nasal Steroid
n=72 Participants
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
n=79 Participants
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
|---|---|---|
|
Childhood Asthma Control Test
|
4.15 units on a scale
Standard Error 0.64
|
4.53 units on a scale
Standard Error 0.65
|
Adverse Events
Nasal Steroid
Serious events: 2 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nasal Steroid
n=179 participants at risk；n=189 participants at risk
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
n=187 participants at risk；n=199 participants at risk
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
|---|---|---|
|
Psychiatric disorders
Depression (hospitalized)
|
0.53%
1/189
|
0.50%
1/199
|
|
General disorders
Anaphylactic reaction
|
0.53%
1/189
|
0.00%
0/199
|
|
General disorders
Dental abscess
|
0.00%
0/189
|
0.50%
1/199
|
|
Vascular disorders
Headache and high blood pressure
|
0.00%
0/189
|
0.50%
1/199
|
|
General disorders
Dehydration
|
0.00%
0/189
|
0.50%
1/199
|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
0.00%
0/189
|
1.0%
2/199
|
|
Infections and infestations
pneumonia
|
0.00%
0/189
|
0.50%
1/199
|
|
Surgical and medical procedures
Fungus ball of the sinus requiring surgery
|
0.00%
0/189
|
0.50%
1/199
|
|
Infections and infestations
appendicitis
|
0.00%
0/189
|
0.50%
1/199
|
Other adverse events
| Measure |
Nasal Steroid
n=179 participants at risk；n=189 participants at risk
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
|
Placebo
n=187 participants at risk；n=199 participants at risk
Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo: Intranasal placebo spray
|
|---|---|---|
|
Vascular disorders
Headache
|
32.1%
45/140
|
37.8%
56/148
|
|
General disorders
Sore throat
|
12.6%
22/174
|
19.4%
34/175
|
|
General disorders
Nasal bleed
|
5.7%
10/176
|
8.2%
15/184
|
|
General disorders
Nasal pain
|
15.4%
25/162
|
26.2%
44/168
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
7/172
|
10.0%
18/180
|
|
Skin and subcutaneous tissue disorders
Itching
|
10.8%
17/157
|
13.9%
23/165
|
|
Ear and labyrinth disorders
Dizzy
|
5.2%
9/172
|
9.4%
17/181
|
|
Infections and infestations
Upper respiratory tract infection
|
15.2%
27/178
|
15.2%
28/184
|
|
Respiratory, thoracic and mediastinal disorders
Trouble breathing
|
30.9%
42/136
|
36.2%
55/152
|
|
General disorders
Swelling
|
5.7%
10/175
|
10.4%
19/183
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.3%
39/133
|
28.0%
44/157
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
8.6%
10/116
|
12.5%
14/112
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place