Trial Outcomes & Findings for Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED) (NCT NCT00442351)
NCT ID: NCT00442351
Last Updated: 2022-02-09
Results Overview
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Twelve (12) weeks
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Asmanex Twisthaler
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
|
Placebo Inhaler
Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
9
|
|
Overall Study
COMPLETED
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Asmanex Twisthaler
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
|
Placebo Inhaler
Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
|
|---|---|---|
|
Overall Study
Administrative
|
6
|
5
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
Baseline characteristics by cohort
| Measure |
Asmanex Twisthaler
n=17 Participants
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
|
Placebo Inhaler
n=9 Participants
Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
|
Total
n=26 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
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
9 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Twelve (12) weeksThe baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.
Outcome measures
Outcome data not reported
Adverse Events
Asmanex Twisthaler
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Inhaler
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asmanex Twisthaler
n=17 participants at risk
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
|
Placebo Inhaler
n=9 participants at risk
Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
|
|---|---|---|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Acute sinusitis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Oral candidiasis
|
5.9%
1/17 • Number of events 2
|
0.00%
0/9
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/17
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.9%
1/17 • Number of events 1
|
0.00%
0/9
|
|
Surgical and medical procedures
Scar excision
|
5.9%
1/17 • Number of events 1
|
0.00%
0/9
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is not allowed to release any interim results of the Study without prior consent of the sponsor, and must provide 45 days written notice to the sponsor prior to public release to permit the sponsor's review. The PI can use the study results for his/her own teaching, research, and publication purposes only, not for commercial purposes, except as authorized by the sponsor. No publication shall contain any trade secret or proprietary/confidential information of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER