Trial Outcomes & Findings for Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma. (NCT NCT00392288)
NCT ID: NCT00392288
Last Updated: 2017-02-01
Results Overview
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to \<12 years only. Least Squares Mean were adjusted for Baseline FEV1, age \[yrs\], pooled center, previous corticosteroid therapy and holding chamber.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
528 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-02-01
Participant Flow
Screening period 7-14 days, randomization with subsequent treatment period over 12 weeks
The number of subjects in section Participant Flow is related to the number of randomized subjects (= subject who were eligible for treatment period). This number is different to the number of subjects of the Intention to Treat (ITT) population in Outcome Measures. The statistical analyses of the Outcome Measures is related to the ITT population.
Participant milestones
| Measure |
Placebo Metered Dose Inhaler (MDI)
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Overall Study
STARTED
|
175
|
177
|
176
|
|
Overall Study
Treatment Period
|
172
|
174
|
175
|
|
Overall Study
COMPLETED
|
143
|
155
|
159
|
|
Overall Study
NOT COMPLETED
|
32
|
22
|
17
|
Reasons for withdrawal
| Measure |
Placebo Metered Dose Inhaler (MDI)
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
17
|
7
|
8
|
|
Overall Study
Lack of Efficacy
|
8
|
5
|
3
|
|
Overall Study
Protocol Violation
|
1
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Parent/legal guardian withdrawal
|
1
|
2
|
1
|
|
Overall Study
Other
|
3
|
4
|
1
|
Baseline Characteristics
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Baseline characteristics by cohort
| Measure |
Placebo Metered Dose Inhaler (MDI)
n=163 Participants
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
n=166 Participants
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
n=172 Participants
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Aged 6 to <12 years
|
136 participants
n=99 Participants
|
138 participants
n=107 Participants
|
145 participants
n=206 Participants
|
419 participants
n=7 Participants
|
|
Age, Customized
Aged 4 to <6 years
|
27 participants
n=99 Participants
|
28 participants
n=107 Participants
|
27 participants
n=206 Participants
|
82 participants
n=7 Participants
|
|
Gender
Female
|
59 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
204 Participants
n=7 Participants
|
|
Gender
Male
|
104 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
297 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and \<12 years.
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to \<12 years only. Least Squares Mean were adjusted for Baseline FEV1, age \[yrs\], pooled center, previous corticosteroid therapy and holding chamber.
Outcome measures
| Measure |
Placebo Metered Dose Inhaler (MDI)
n=136 Participants
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
n=138 Participants
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
n=146 Participants
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.
|
5.2 Percent of predicted FEV1
Standard Error 1.06
|
5.3 Percent of predicted FEV1
Standard Error 1.06
|
7.7 Percent of predicted FEV1
Standard Error 1.06
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.
Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)
Outcome measures
| Measure |
Placebo Metered Dose Inhaler (MDI)
n=161 Participants
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
n=165 Participants
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
n=170 Participants
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Change From Baseline in Total Daily Asthma Symptom Score at Week 12.
|
-0.96 Scores on a scale
Standard Error 0.08
|
-1.13 Scores on a scale
Standard Error 0.08
|
-0.99 Scores on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.
Change in albuterol/salbutamol use from baseline to week 12
Outcome measures
| Measure |
Placebo Metered Dose Inhaler (MDI)
n=162 Participants
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
n=166 Participants
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
n=172 Participants
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Change From Baseline in Use of Albuterol/Salbutamol at Week 12.
|
-0.59 Puffs per day
Standard Error 0.08
|
-0.87 Puffs per day
Standard Error 0.08
|
-0.93 Puffs per day
Standard Error 0.08
|
Adverse Events
Placebo Metered Dose Inhaler (MDI)
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Ciclesonide MDI 40 µg BID
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Ciclesonide MDI 80 µg BID
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Metered Dose Inhaler (MDI)
n=172 participants at risk
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
n=174 participants at risk
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
n=175 participants at risk
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.58%
1/172 • Number of events 1
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.00%
0/174
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
1.1%
2/175 • Number of events 2
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
Musculoskeletal and connective tissue disorders
Forearm fracture
|
0.00%
0/172
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.57%
1/174 • Number of events 1
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.00%
0/175
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/172
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.00%
0/174
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.57%
1/175 • Number of events 1
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
General disorders
Electric shock
|
0.00%
0/172
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.00%
0/174
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
0.57%
1/175 • Number of events 1
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
Other adverse events
| Measure |
Placebo Metered Dose Inhaler (MDI)
n=172 participants at risk
Placebo MDI over twelve weeks (ITT population)
|
Ciclesonide MDI 40 µg BID
n=174 participants at risk
Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
|
Ciclesonide MDI 80 µg BID
n=175 participants at risk
Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.9%
5/172 • Number of events 5
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
6.9%
12/174 • Number of events 18
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
4.6%
8/175 • Number of events 9
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.5%
18/172 • Number of events 18
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
5.7%
10/174 • Number of events 10
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
1.7%
3/175 • Number of events 3
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
9/172 • Number of events 11
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
4.6%
8/174 • Number of events 9
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
4.0%
7/175 • Number of events 7
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
11/172 • Number of events 11
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
2.3%
4/174 • Number of events 5
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
5.7%
10/175 • Number of events 10
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
|
Infections and infestations
Pharyngitis
|
9.9%
17/172 • Number of events 19
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
4.0%
7/174 • Number of events 7
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
2.3%
4/175 • Number of events 4
The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60