Trial Outcomes & Findings for Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295) (NCT NCT00394914)
NCT ID: NCT00394914
Last Updated: 2015-07-16
Results Overview
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
311 participants
Primary outcome timeframe
From time of exposure to index case to end of Follow-up Period (21 days)
Results posted on
2015-07-16
Participant Flow
All enrolled participants were screened. After the screening visit and before randomization, participants received weekly phone calls and revisited the site once per month during a Pre-exposure Period until exposed to a household member with a cold (index case).
Participant milestones
| Measure |
All Participants (Pre-randomization)
All participants on study prior to randomization.
|
Pleconaril
Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|---|
|
Screening Period
STARTED
|
311
|
0
|
0
|
|
Screening Period
COMPLETED
|
311
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Pre-exposure Period
STARTED
|
311
|
0
|
0
|
|
Pre-exposure Period
COMPLETED
|
311
|
0
|
0
|
|
Pre-exposure Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
154
|
157
|
|
Treatment Period
COMPLETED
|
0
|
144
|
151
|
|
Treatment Period
NOT COMPLETED
|
0
|
10
|
6
|
Reasons for withdrawal
| Measure |
All Participants (Pre-randomization)
All participants on study prior to randomization.
|
Pleconaril
Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|---|
|
Treatment Period
Adverse Event
|
0
|
3
|
1
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
2
|
2
|
|
Treatment Period
Noncompliance with protocol
|
0
|
3
|
2
|
|
Treatment Period
Did not meet protocol eligibility
|
0
|
1
|
1
|
Baseline Characteristics
Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)
Baseline characteristics by cohort
| Measure |
Pleconaril
n=154 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=157 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 16.7 • n=93 Participants
|
28.7 years
STANDARD_DEVIATION 17.3 • n=4 Participants
|
29.1 years
STANDARD_DEVIATION 17.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
182 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
129 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From time of exposure to index case to end of Follow-up Period (21 days)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine rhinovirus cold.
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Outcome measures
| Measure |
Pleconaril
n=154 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=157 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
Percentage of Participants With Rhinovirus PCR-Positive Colds
|
2.6 percentage of participants
|
2.5 percentage of participants
|
PRIMARY outcome
Timeframe: From time of exposure to index case to end of Follow-up Period (21 days)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine exacerbation.
Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Outcome measures
| Measure |
Pleconaril
n=154 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=157 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
|
1.3 percentage of participants
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some ACQ follow-up information.
The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.
Outcome measures
| Measure |
Pleconaril
n=126 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=127 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
Baseline (n=126, n=127)
|
0.86 units on a scale
Standard Deviation 0.72
|
0.87 units on a scale
Standard Deviation 0.72
|
|
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
Change From BL to Day 8 (n=120, n=124)
|
-0.11 units on a scale
Standard Deviation 0.52
|
-0.06 units on a scale
Standard Deviation 0.52
|
|
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
Change From BL to Day 14 (n=94, n=96)
|
-0.09 units on a scale
Standard Deviation 0.58
|
-0.15 units on a scale
Standard Deviation 0.58
|
|
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
Change From BL to Day 21 (n=89, n=96)
|
-0.12 units on a scale
Standard Deviation 0.56
|
-0.02 units on a scale
Standard Deviation 0.56
|
|
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
Change From BL to Final Visit (n=126, n=127)
|
-0.09 units on a scale
Standard Deviation 0.56
|
-0.00 units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some FEV1 follow-up information.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=152 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=156 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline (n=152, n=156)
|
2.335 liters
Standard Deviation 0.728
|
2.214 liters
Standard Deviation 0.728
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Day 2 (n=111, n=115)
|
-0.091 liters
Standard Deviation 0.267
|
-0.100 liters
Standard Deviation 0.267
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Day 4 (n=97, n=102)
|
-0.059 liters
Standard Deviation 0.273
|
-0.141 liters
Standard Deviation 0.273
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Day 8 (n=132, n=135)
|
-0.070 liters
Standard Deviation 0.274
|
-0.121 liters
Standard Deviation 0.274
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Day 10 (n=116, n=120)
|
-0.090 liters
Standard Deviation 0.271
|
-0.109 liters
Standard Deviation 0.271
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Day 14 (n=140, n=139)
|
-0.063 liters
Standard Deviation 0.266
|
-0.090 liters
Standard Deviation 0.266
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Day 21 (n=141, n=146)
|
-0.080 liters
Standard Deviation 0.287
|
-0.133 liters
Standard Deviation 0.287
|
|
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From BL to Final Visit (n=152, n=156)
|
-0.076 liters
Standard Deviation 0.291
|
-0.141 liters
Standard Deviation 0.291
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.
PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=124 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=136 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Baseline (n=124, n=136)
|
306.2 L/min
Standard Deviation 96.8
|
284.0 L/min
Standard Deviation 96.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 2 (n=108, n=123)
|
-0.1 L/min
Standard Deviation 55.4
|
-1.9 L/min
Standard Deviation 55.4
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 3 (n=103, n=120)
|
9.9 L/min
Standard Deviation 57.7
|
6.1 L/min
Standard Deviation 57.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 4 (n=103, n=118)
|
5.1 L/min
Standard Deviation 59.1
|
-1.1 L/min
Standard Deviation 59.1
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 5 (n=96, n=122)
|
0.2 L/min
Standard Deviation 45.9
|
-3.4 L/min
Standard Deviation 45.9
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 6 (n=104, n=114)
|
0.2 L/min
Standard Deviation 60.3
|
2.5 L/min
Standard Deviation 60.3
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 7 (n=102, n=112)
|
2.5 L/min
Standard Deviation 57.5
|
-4.0 L/min
Standard Deviation 57.5
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 8 (n=102, n=116)
|
-0.6 L/min
Standard Deviation 47.0
|
-0.9 L/min
Standard Deviation 47.0
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 9 (n=105, n=114)
|
13.6 L/min
Standard Deviation 63.9
|
8.1 L/min
Standard Deviation 63.9
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 10 (n=90, n=102)
|
7.7 L/min
Standard Deviation 54.6
|
0.6 L/min
Standard Deviation 54.6
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 11 (n=95, n=108)
|
-3.9 L/min
Standard Deviation 51.4
|
-0.6 L/min
Standard Deviation 51.4
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 12 (n=94, n=102)
|
3.2 L/min
Standard Deviation 77.8
|
11.5 L/min
Standard Deviation 77.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 13 (n=88, n=97)
|
4.7 L/min
Standard Deviation 55.3
|
7.7 L/min
Standard Deviation 55.3
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 14 (n=90, n=103)
|
3.4 L/min
Standard Deviation 69.3
|
23.5 L/min
Standard Deviation 69.3
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 15 (n=91, n=107)
|
-3.2 L/min
Standard Deviation 76.8
|
3.9 L/min
Standard Deviation 76.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 16 (n=92, n=101)
|
4.4 L/min
Standard Deviation 49.5
|
-1.7 L/min
Standard Deviation 49.5
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 17 (n=74, n=93)
|
6.0 L/min
Standard Deviation 51.0
|
-6.9 L/min
Standard Deviation 51.0
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 18 (n=80, n=98)
|
0.7 L/min
Standard Deviation 57.9
|
10.8 L/min
Standard Deviation 57.9
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 19 (n=81, n=102)
|
1.2 L/min
Standard Deviation 62.7
|
4.1 L/min
Standard Deviation 62.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 20 (n=76, n=88)
|
10.2 L/min
Standard Deviation 58.0
|
10.4 L/min
Standard Deviation 58.0
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Day 21 (n=62, n=85)
|
10.5 L/min
Standard Deviation 49.1
|
-1.4 L/min
Standard Deviation 49.1
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Final Day (n=124, n=136)
|
4.6 L/min
Standard Deviation 57.8
|
-5.2 L/min
Standard Deviation 57.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Week 1 (n=122, n=136)
|
-0.7 L/min
Standard Deviation 39.2
|
-2.2 L/min
Standard Deviation 39.2
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Week 2 (n=119, n=134)
|
1.4 L/min
Standard Deviation 45.9
|
4.5 L/min
Standard Deviation 45.9
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Week 3 (n=109, n=127)
|
5.2 L/min
Standard Deviation 48.7
|
-1.1 L/min
Standard Deviation 48.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Change From BL to Final Week (n=124, n=136)
|
2.3 L/min
Standard Deviation 49.8
|
-3.8 L/min
Standard Deviation 49.8
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.
PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=119 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=128 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Week 2 (n=113, n=124)
|
3.4 L/min
Standard Deviation 49.2
|
6.0 L/min
Standard Deviation 49.2
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Baseline (n=119, n=128)
|
310.9 L/min
Standard Deviation 93.6
|
293.4 L/min
Standard Deviation 93.6
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 1 (n=93, n=105)
|
0.4 L/min
Standard Deviation 48.2
|
1.0 L/min
Standard Deviation 48.2
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 2 (n=102, n=115)
|
2.0 L/min
Standard Deviation 57.7
|
0.4 L/min
Standard Deviation 57.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 3 (n=98, n=112)
|
2.3 L/min
Standard Deviation 45.6
|
-14.7 L/min
Standard Deviation 45.6
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 4 (n=98, n=108)
|
8.2 L/min
Standard Deviation 54.2
|
3.1 L/min
Standard Deviation 54.2
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 5 (n=105, n=109)
|
-3.7 L/min
Standard Deviation 57.0
|
1.6 L/min
Standard Deviation 57.0
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 6 (n=98, n=108)
|
-3.5 L/min
Standard Deviation 46.3
|
-9.8 L/min
Standard Deviation 46.3
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 7 (n=95, n=106)
|
10.0 L/min
Standard Deviation 59.1
|
-1.6 L/min
Standard Deviation 59.1
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 8 (n=94, n=106)
|
11.2 L/min
Standard Deviation 76.7
|
20.2 L/min
Standard Deviation 76.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 9 (n=91, n=103)
|
3.5 L/min
Standard Deviation 52.6
|
-3.4 L/min
Standard Deviation 52.6
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 10 (n=91, n=99)
|
9.2 L/min
Standard Deviation 58.9
|
9.1 L/min
Standard Deviation 58.9
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 11 (n=83, n=97)
|
-3.0 L/min
Standard Deviation 62.7
|
1.0 L/min
Standard Deviation 62.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 12 (n=82, n=90)
|
-2.6 L/min
Standard Deviation 71.5
|
8.9 L/min
Standard Deviation 71.5
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 13 (n=85, n=98)
|
9.3 L/min
Standard Deviation 56.4
|
8.1 L/min
Standard Deviation 56.4
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 14 (n=80, n=98)
|
2.4 L/min
Standard Deviation 48.6
|
1.7 L/min
Standard Deviation 48.6
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 15 (n=88, n=89)
|
-0.2 L/min
Standard Deviation 49.7
|
-9.0 L/min
Standard Deviation 49.7
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 16 (n=82, n=84)
|
-6.8 L/min
Standard Deviation 49.4
|
-6.1 L/min
Standard Deviation 49.4
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 17 (n=81, n=93)
|
-1.1 L/min
Standard Deviation 54.8
|
-1.1 L/min
Standard Deviation 54.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 18 (n=84, n=97)
|
3.2 L/min
Standard Deviation 59.4
|
3.7 L/min
Standard Deviation 59.4
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 19 (n=80, n=93)
|
-1.0 L/min
Standard Deviation 55.8
|
12.3 L/min
Standard Deviation 55.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 20 (n=78, n=80)
|
16.2 L/min
Standard Deviation 64.8
|
12.6 L/min
Standard Deviation 64.8
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Day 21 (n=47, n=63)
|
-7.5 L/min
Standard Deviation 96.1
|
12.3 L/min
Standard Deviation 96.1
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Final Day (n=119, n=128)
|
10.4 L/min
Standard Deviation 81.1
|
14.7 L/min
Standard Deviation 81.1
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Week 1 (n=116, n=127)
|
2.5 L/min
Standard Deviation 38.4
|
-2.0 L/min
Standard Deviation 38.4
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Week 3 (n=103, n=117)
|
-3.5 L/min
Standard Deviation 49.5
|
3.5 L/min
Standard Deviation 49.5
|
|
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Change From BL to Final Week (n=119, n=128)
|
3.1 L/min
Standard Deviation 53.6
|
8.1 L/min
Standard Deviation 53.6
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some cold symptom score follow-up information.
Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=147 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=153 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Baseline (n=147, n=153)
|
1.09 units on a scale
Standard Deviation 1.62
|
0.99 units on a scale
Standard Deviation 1.62
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 1 (n=135, n=143)
|
0.03 units on a scale
Standard Deviation 1.05
|
0.12 units on a scale
Standard Deviation 1.05
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 2 (n=143, n=152)
|
0.21 units on a scale
Standard Deviation 1.08
|
0.26 units on a scale
Standard Deviation 1.08
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 3 (n=141, n=152)
|
0.31 units on a scale
Standard Deviation 1.34
|
0.35 units on a scale
Standard Deviation 1.34
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 4 (n=142, n=152)
|
0.14 units on a scale
Standard Deviation 1.41
|
0.39 units on a scale
Standard Deviation 1.41
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 5 (n=140, n=152)
|
0.04 units on a scale
Standard Deviation 1.43
|
0.45 units on a scale
Standard Deviation 1.43
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 6 (n=136, n=152)
|
-0.01 units on a scale
Standard Deviation 1.51
|
0.40 units on a scale
Standard Deviation 1.51
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 7 (n=139, n=150)
|
0.03 units on a scale
Standard Deviation 1.65
|
0.38 units on a scale
Standard Deviation 1.65
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 8 (n=139, n=149)
|
0.02 units on a scale
Standard Deviation 1.63
|
0.34 units on a scale
Standard Deviation 1.63
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 9 (n=138, n=150)
|
0.04 units on a scale
Standard Deviation 1.63
|
0.29 units on a scale
Standard Deviation 1.63
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 10 (n=139, n=150)
|
0.18 units on a scale
Standard Deviation 1.71
|
0.29 units on a scale
Standard Deviation 1.71
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 11 (n=137, n=149)
|
0.17 units on a scale
Standard Deviation 1.81
|
0.31 units on a scale
Standard Deviation 1.81
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 12 (n=137, n=148)
|
0.07 units on a scale
Standard Deviation 1.77
|
0.25 units on a scale
Standard Deviation 1.77
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 13 (n=136, n=146)
|
-0.02 units on a scale
Standard Deviation 1.66
|
0.11 units on a scale
Standard Deviation 1.66
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 14 (n=138, n=146)
|
0.05 units on a scale
Standard Deviation 1.51
|
0.15 units on a scale
Standard Deviation 1.51
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 15 (n=135, n=144)
|
0.04 units on a scale
Standard Deviation 1.65
|
0.18 units on a scale
Standard Deviation 1.65
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 16 (n=132, n=144)
|
0.04 units on a scale
Standard Deviation 1.71
|
0.21 units on a scale
Standard Deviation 1.71
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 17 (n=133, n=145)
|
-0.06 units on a scale
Standard Deviation 1.52
|
0.10 units on a scale
Standard Deviation 1.52
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 18 (n=137, n=146)
|
-0.17 units on a scale
Standard Deviation 1.64
|
-0.03 units on a scale
Standard Deviation 1.64
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 19 (n=132, n=145)
|
-0.03 units on a scale
Standard Deviation 1.74
|
-0.04 units on a scale
Standard Deviation 1.74
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 20 (n=126, n=136)
|
-0.04 units on a scale
Standard Deviation 1.63
|
0.17 units on a scale
Standard Deviation 1.63
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Day 21 (n=108, n=121)
|
0.15 units on a scale
Standard Deviation 1.44
|
0.29 units on a scale
Standard Deviation 1.44
|
|
LS Mean Change From Baseline in Total Cold Symptom Score
Change From BL to Final Day (n=147, n=153)
|
0.18 units on a scale
Standard Deviation 1.58
|
0.23 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some asthma symptom score follow-up information.
Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=147 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=153 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Baseline (n=147, n=153)
|
0.67 units on a scale
Standard Deviation 1.03
|
0.56 units on a scale
Standard Deviation 1.03
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 1 (n=135, n=143)
|
0.02 units on a scale
Standard Deviation 0.71
|
0.08 units on a scale
Standard Deviation 0.71
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 2 (n=143, n=152)
|
0.05 units on a scale
Standard Deviation 0.60
|
0.07 units on a scale
Standard Deviation 0.60
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 3 (n=141, n=152)
|
0.04 units on a scale
Standard Deviation 0.65
|
0.09 units on a scale
Standard Deviation 0.65
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 4 (n=142, n=152)
|
-0.04 units on a scale
Standard Deviation 0.77
|
0.09 units on a scale
Standard Deviation 0.77
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 5 (n=140, n=152)
|
-0.10 units on a scale
Standard Deviation 0.81
|
0.15 units on a scale
Standard Deviation 0.81
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 6 (n=136, n=152)
|
-0.10 units on a scale
Standard Deviation 0.88
|
0.15 units on a scale
Standard Deviation 0.88
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 7 (n=139, n=150)
|
-0.07 units on a scale
Standard Deviation 0.90
|
0.18 units on a scale
Standard Deviation 0.90
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 8 (n=139, n=149)
|
-0.07 units on a scale
Standard Deviation 0.95
|
0.12 units on a scale
Standard Deviation 0.95
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 9 (n=138, n=150)
|
-0.07 units on a scale
Standard Deviation 0.88
|
0.10 units on a scale
Standard Deviation 0.88
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 10 (n=139, n=150)
|
-0.01 units on a scale
Standard Deviation 0.96
|
0.15 units on a scale
Standard Deviation 0.96
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 11 (n=137, n=149)
|
-0.05 units on a scale
Standard Deviation 1.02
|
0.17 units on a scale
Standard Deviation 1.02
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 12 (n=137, n=148)
|
-0.02 units on a scale
Standard Deviation 1.02
|
0.09 units on a scale
Standard Deviation 1.02
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 13 (n=136, n=146)
|
-0.06 units on a scale
Standard Deviation 0.92
|
0.02 units on a scale
Standard Deviation 0.92
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 14 (n=138, n=146)
|
-0.07 units on a scale
Standard Deviation 0.85
|
0.03 units on a scale
Standard Deviation 0.85
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 15 (n=135, n=144)
|
-0.11 units on a scale
Standard Deviation 0.86
|
0.08 units on a scale
Standard Deviation 0.86
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 16 (n=132, n=144)
|
-0.16 units on a scale
Standard Deviation 0.93
|
0.04 units on a scale
Standard Deviation 0.93
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 17 (n=133, n=145)
|
-0.18 units on a scale
Standard Deviation 0.84
|
0.00 units on a scale
Standard Deviation 0.84
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 18 (n=137, n=146)
|
-0.14 units on a scale
Standard Deviation 0.91
|
-0.05 units on a scale
Standard Deviation 0.91
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 19 (n=132, n=145)
|
-0.14 units on a scale
Standard Deviation 1.03
|
-0.04 units on a scale
Standard Deviation 1.03
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 20 (n=126, n=136)
|
-0.15 units on a scale
Standard Deviation 0.97
|
-0.01 units on a scale
Standard Deviation 0.97
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Day 21 (n=108, n=121)
|
-0.10 units on a scale
Standard Deviation 0.93
|
0.06 units on a scale
Standard Deviation 0.93
|
|
LS Mean Change From Baseline in Total Asthma Symptom Score
Change From BL to Final Day (n=147, n=153)
|
-0.09 units on a scale
Standard Deviation 0.94
|
0.03 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some SABA follow-up information.
SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=143 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=148 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Baseline (n=143, n=148)
|
0.99 number of puffs of SABA
Standard Deviation 2.43
|
0.81 number of puffs of SABA
Standard Deviation 2.43
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 1 (n=131, n=138)
|
0.15 number of puffs of SABA
Standard Deviation 2.37
|
-0.15 number of puffs of SABA
Standard Deviation 2.37
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 2 (n=137, n=146)
|
0.19 number of puffs of SABA
Standard Deviation 3.75
|
-0.16 number of puffs of SABA
Standard Deviation 3.75
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 3 (n=135, n=146)
|
0.29 number of puffs of SABA
Standard Deviation 3.17
|
0.03 number of puffs of SABA
Standard Deviation 3.17
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 4 (n=137, n=147)
|
0.17 number of puffs of SABA
Standard Deviation 2.01
|
0.23 number of puffs of SABA
Standard Deviation 2.01
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 5 (n=135, n=147)
|
0.04 number of puffs of SABA
Standard Deviation 1.86
|
0.27 number of puffs of SABA
Standard Deviation 1.86
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 6 (n=131, n=146)
|
-0.05 number of puffs of SABA
Standard Deviation 1.45
|
0.12 number of puffs of SABA
Standard Deviation 1.45
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 7 (n=135, n=144)
|
0.17 number of puffs of SABA
Standard Deviation 1.88
|
0.19 number of puffs of SABA
Standard Deviation 1.88
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 8 (n=129, n=141)
|
-0.09 number of puffs of SABA
Standard Deviation 1.63
|
0.06 number of puffs of SABA
Standard Deviation 1.63
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 9 (n=131, n=142)
|
-0.24 number of puffs of SABA
Standard Deviation 1.76
|
-0.14 number of puffs of SABA
Standard Deviation 1.76
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 10 (n=130, n=144)
|
-0.26 number of puffs of SABA
Standard Deviation 1.76
|
-0.14 number of puffs of SABA
Standard Deviation 1.76
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 11 (n=128, n=141)
|
-0.13 number of puffs of SABA
Standard Deviation 1.92
|
-0.05 number of puffs of SABA
Standard Deviation 1.92
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 12 (n=129, n=139)
|
0.01 number of puffs of SABA
Standard Deviation 2.38
|
-0.12 number of puffs of SABA
Standard Deviation 2.38
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 13 (n=130, n=139)
|
0.03 number of puffs of SABA
Standard Deviation 3.05
|
-0.14 number of puffs of SABA
Standard Deviation 3.05
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 14 (n=131, n=140)
|
0.20 number of puffs of SABA
Standard Deviation 3.08
|
-0.07 number of puffs of SABA
Standard Deviation 3.08
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 15 (n=126, n=137)
|
0.40 number of puffs of SABA
Standard Deviation 4.12
|
-0.11 number of puffs of SABA
Standard Deviation 4.12
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 16 (n=126, n=136)
|
0.32 number of puffs of SABA
Standard Deviation 2.45
|
0.26 number of puffs of SABA
Standard Deviation 2.45
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 17 (n=127, n=138)
|
-0.00 number of puffs of SABA
Standard Deviation 2.13
|
0.01 number of puffs of SABA
Standard Deviation 2.13
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 18 (n=130, n=139)
|
-0.30 number of puffs of SABA
Standard Deviation 2.07
|
0.07 number of puffs of SABA
Standard Deviation 2.07
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 19 (n=121, n=133)
|
0.10 number of puffs of SABA
Standard Deviation 2.25
|
0.11 number of puffs of SABA
Standard Deviation 2.25
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 20 (n=108, n=118)
|
0.19 number of puffs of SABA
Standard Deviation 2.15
|
0.39 number of puffs of SABA
Standard Deviation 2.15
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Day 21 (n=78, n=83)
|
0.25 number of puffs of SABA
Standard Deviation 1.76
|
0.11 number of puffs of SABA
Standard Deviation 1.76
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Final Day (n=143, n=148)
|
-0.05 number of puffs of SABA
Standard Deviation 2.11
|
0.12 number of puffs of SABA
Standard Deviation 2.11
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Week 1 (n=142, n=148)
|
0.15 number of puffs of SABA
Standard Deviation 2.10
|
0.08 number of puffs of SABA
Standard Deviation 2.10
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Week 2 (n=139, n=146)
|
0.06 number of puffs of SABA
Standard Deviation 2.88
|
-0.12 number of puffs of SABA
Standard Deviation 2.88
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Week 3 (n=135, n=145)
|
0.08 number of puffs of SABA
Standard Deviation 1.93
|
0.22 number of puffs of SABA
Standard Deviation 1.93
|
|
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Change From BL to Final Week (n=143, n=148)
|
0.09 number of puffs of SABA
Standard Deviation 1.90
|
0.21 number of puffs of SABA
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: Baseline through the Final Visit (Day 21)Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some sleep follow-up information.
Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.
Outcome measures
| Measure |
Pleconaril
n=146 Participants
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=153 Participants
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 8 (n=137, n=147)
|
-0.06 units on a scale
Standard Deviation 0.37
|
0.03 units on a scale
Standard Deviation 0.37
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 9 (n=136, n=148)
|
-0.04 units on a scale
Standard Deviation 0.39
|
-0.00 units on a scale
Standard Deviation 0.39
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 10 (n=136, n=149)
|
-0.02 units on a scale
Standard Deviation 0.41
|
-0.02 units on a scale
Standard Deviation 0.41
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 11 (n=135, n=148)
|
-0.03 units on a scale
Standard Deviation 0.40
|
-0.02 units on a scale
Standard Deviation 0.40
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 12 (n=135, n=146)
|
0.01 units on a scale
Standard Deviation 0.39
|
-0.02 units on a scale
Standard Deviation 0.39
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 13 (n=134, n=146)
|
-0.04 units on a scale
Standard Deviation 0.36
|
-0.01 units on a scale
Standard Deviation 0.36
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 14 (n=133, n=146)
|
-0.04 units on a scale
Standard Deviation 0.38
|
-0.01 units on a scale
Standard Deviation 0.38
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 15 (n=132, n=142)
|
-0.01 units on a scale
Standard Deviation 0.46
|
0.04 units on a scale
Standard Deviation 0.46
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 16 (n=129, n=138)
|
-0.03 units on a scale
Standard Deviation 0.39
|
0.01 units on a scale
Standard Deviation 0.39
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 17 (n=127, n=141)
|
-0.01 units on a scale
Standard Deviation 0.36
|
-0.03 units on a scale
Standard Deviation 0.36
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 18 (n=131, n=145)
|
-0.03 units on a scale
Standard Deviation 0.34
|
-0.05 units on a scale
Standard Deviation 0.34
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 19 (n=129, n=144)
|
-0.03 units on a scale
Standard Deviation 0.38
|
-0.03 units on a scale
Standard Deviation 0.38
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 20 (n=123, n=133)
|
-0.06 units on a scale
Standard Deviation 0.39
|
0.02 units on a scale
Standard Deviation 0.39
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 21 (n=107, n=121)
|
-0.04 units on a scale
Standard Deviation 0.35
|
0.05 units on a scale
Standard Deviation 0.35
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Final Day (n=146, n=153)
|
-0.02 units on a scale
Standard Deviation 0.43
|
0.04 units on a scale
Standard Deviation 0.43
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Week 1 (n=145, n=153)
|
0.00 units on a scale
Standard Deviation 0.27
|
0.03 units on a scale
Standard Deviation 0.27
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Week 2 (n=142, n=152)
|
-0.05 units on a scale
Standard Deviation 0.33
|
0.00 units on a scale
Standard Deviation 0.33
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Week 3 (n=138, n=150)
|
-0.02 units on a scale
Standard Deviation 0.35
|
-0.01 units on a scale
Standard Deviation 0.35
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Final Week (n=146, n=153)
|
-0.03 units on a scale
Standard Deviation 0.36
|
-0.00 units on a scale
Standard Deviation 0.36
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Baseline (n=146, n=153)
|
0.12 units on a scale
Standard Deviation 0.29
|
0.07 units on a scale
Standard Deviation 0.29
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 2 (n=141, n=152)
|
0.06 units on a scale
Standard Deviation 0.34
|
0.01 units on a scale
Standard Deviation 0.34
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 3 (n=140, n=152)
|
0.02 units on a scale
Standard Deviation 0.39
|
0.04 units on a scale
Standard Deviation 0.39
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 4 (n=141, n=151)
|
0.00 units on a scale
Standard Deviation 0.37
|
0.03 units on a scale
Standard Deviation 0.37
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 5 (n=138, n=152)
|
-0.01 units on a scale
Standard Deviation 0.37
|
0.02 units on a scale
Standard Deviation 0.37
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 6 (n=135, n=151)
|
-0.02 units on a scale
Standard Deviation 0.38
|
0.05 units on a scale
Standard Deviation 0.38
|
|
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Change From BL to Day 7 (n=136, n=149)
|
-0.05 units on a scale
Standard Deviation 0.40
|
0.05 units on a scale
Standard Deviation 0.40
|
Adverse Events
Pleconaril
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pleconaril
n=154 participants at risk
Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
|
Placebo
n=157 participants at risk
Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.9%
6/154 • Number of events 6 • AE data is reported from the time of randomization to the end of the Follow-up Period (Day 21). The Screening Period and Pre-Exposure Periods are not included in this time frame.
|
5.7%
9/157 • Number of events 14 • AE data is reported from the time of randomization to the end of the Follow-up Period (Day 21). The Screening Period and Pre-Exposure Periods are not included in this time frame.
|
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 investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts.
- Publication restrictions are in place
Restriction type: OTHER