Trial Outcomes & Findings for Safety and Efficacy of AL-53817 Nasal Spray Solution (NCT NCT01454505)
NCT ID: NCT01454505
Last Updated: 2013-05-20
Results Overview
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
110 participants
Primary outcome timeframe
Day 1
Results posted on
2013-05-20
Participant Flow
Subjects were recruited from one study center in Canada.
50 healthy volunteers were enrolled in Stage A and subsequently exited from the study. 60 unique patients were enrolled in Stage B.
Participant milestones
| Measure |
Stage A/AL-53817
AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
|
Stage A/Vehicle
Vehicle, 1 or 2 sprays per nostril, single dose
|
Stage B/AL-53817
AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
|
Stage B/Vehicle
Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
15
|
40
|
20
|
|
Overall Study
COMPLETED
|
35
|
15
|
40
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of AL-53817 Nasal Spray Solution
Baseline characteristics by cohort
| Measure |
Stage A/Healthy Volunteers
n=50 Participants
AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
|
Stage B/AL-53817
n=40 Participants
AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
|
Stage B/Vehicle
n=20 Participants
Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65
|
49 participants
n=5 Participants
|
39 participants
n=7 Participants
|
20 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Age, Customized
≥65
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=5 Participants
|
40 participants
n=7 Participants
|
20 participants
n=5 Participants
|
110 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: This reporting group includes all subjects exposed to test article during Stage A.
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Outcome measures
| Measure |
Stage A/AL-53817
n=35 Participants
AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
|
Stage A/Vehicle
n=15 Participants
Vehicle, 1 or 2 sprays per nostril, single dose
|
|---|---|---|
|
Number of Adverse Events in Stage A
Adverse events, not including serious
|
9 Adverse Events
|
3 Adverse Events
|
|
Number of Adverse Events in Stage A
Serious adverse events, not including deaths
|
0 Adverse Events
|
0 Adverse Events
|
|
Number of Adverse Events in Stage A
Deaths
|
0 Adverse Events
|
0 Adverse Events
|
PRIMARY outcome
Timeframe: Baseline (pretreatment), Day 5Population: Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.
Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Outcome measures
| Measure |
Stage A/AL-53817
n=40 Participants
AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
|
Stage A/Vehicle
n=20 Participants
Vehicle, 1 or 2 sprays per nostril, single dose
|
|---|---|---|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
0.5 hour
|
-0.5 Units on a scale
Standard Deviation 0.7
|
-0.1 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
0.75 hour
|
-0.6 Units on a scale
Standard Deviation 0.7
|
-0.3 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
1 hour
|
-0.6 Units on a scale
Standard Deviation 0.9
|
-0.3 Units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
2 hours
|
-0.6 Units on a scale
Standard Deviation 0.9
|
-0.2 Units on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
2.5 hours
|
-0.7 Units on a scale
Standard Deviation 0.8
|
-0.1 Units on a scale
Standard Deviation 0.8
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
3 hours
|
-0.5 Units on a scale
Standard Deviation 0.8
|
-0.1 Units on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
3.5 hours
|
-0.7 Units on a scale
Standard Deviation 0.9
|
-0.2 Units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
4.5 hours
|
-0.7 Units on a scale
Standard Deviation 0.8
|
-0.3 Units on a scale
Standard Deviation 0.9
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
5 hours
|
-0.7 Units on a scale
Standard Deviation 0.9
|
-0.2 Units on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
5.5 hours
|
-0.6 Units on a scale
Standard Deviation 0.9
|
-0.2 Units on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
6 hours
|
-0.6 Units on a scale
Standard Deviation 0.8
|
-0.2 Units on a scale
Standard Deviation 0.9
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
0 hour
|
0.1 Units on a scale
Standard Deviation 0.7
|
0.1 Units on a scale
Standard Deviation 0.8
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
0.25 hour
|
-0.1 Units on a scale
Standard Deviation 0.9
|
0.2 Units on a scale
Standard Deviation 0.8
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
1.5 hours
|
-0.8 Units on a scale
Standard Deviation 0.8
|
0.0 Units on a scale
Standard Deviation 1.0
|
|
Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5
4 hours
|
-0.6 Units on a scale
Standard Deviation 1.0
|
-0.3 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline (pretreatment), Day 5Population: Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.
Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
Outcome measures
| Measure |
Stage A/AL-53817
n=40 Participants
AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
|
Stage A/Vehicle
n=20 Participants
Vehicle, 1 or 2 sprays per nostril, single dose
|
|---|---|---|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
0 hour
|
-0.3 Units on a scale
Standard Deviation 2.3
|
0.3 Units on a scale
Standard Deviation 1.7
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
0.25 hour
|
-0.7 Units on a scale
Standard Deviation 2.8
|
0.8 Units on a scale
Standard Deviation 2.4
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
0.5 hour
|
-1.5 Units on a scale
Standard Deviation 2.5
|
0.1 Units on a scale
Standard Deviation 1.8
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
1 hour
|
-2.3 Units on a scale
Standard Deviation 3.2
|
-1.1 Units on a scale
Standard Deviation 2.5
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
1.5 hour
|
-3.1 Units on a scale
Standard Deviation 2.9
|
-0.3 Units on a scale
Standard Deviation 3.5
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
2 hours
|
-2.8 Units on a scale
Standard Deviation 3.1
|
-1.3 Units on a scale
Standard Deviation 3.2
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
2.5 hours
|
-2.8 Units on a scale
Standard Deviation 3.2
|
-0.8 Units on a scale
Standard Deviation 3.2
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
3 hours
|
-2.2 Units on a scale
Standard Deviation 2.9
|
-0.5 Units on a scale
Standard Deviation 2.6
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
3.5 hours
|
-2.9 Units on a scale
Standard Deviation 2.8
|
-0.8 Units on a scale
Standard Deviation 2.9
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
4 hours
|
-2.7 Units on a scale
Standard Deviation 3.1
|
-1.3 Units on a scale
Standard Deviation 2.6
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
4.5 hours
|
-2.7 Units on a scale
Standard Deviation 2.6
|
-1.4 Units on a scale
Standard Deviation 3.1
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
5 hours
|
-2.7 Units on a scale
Standard Deviation 2.8
|
-1.3 Units on a scale
Standard Deviation 2.8
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
5.5 hours
|
-2.7 Units on a scale
Standard Deviation 3.2
|
-1.4 Units on a scale
Standard Deviation 3.4
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
6 hours
|
-2.3 Units on a scale
Standard Deviation 2.7
|
-1.0 Units on a scale
Standard Deviation 2.8
|
|
Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5
0.75 hour
|
-2.3 Units on a scale
Standard Deviation 2.8
|
-0.9 Units on a scale
Standard Deviation 2.5
|
Adverse Events
Stage A/AL-53817
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Stage A/Vehicle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage B/AL-53817
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Stage B/Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stage A/AL-53817
n=35 participants at risk
AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
|
Stage A/Vehicle
n=15 participants at risk
Vehicle, 1 or 2 sprays per nostril, single dose
|
Stage B/AL-53817
n=40 participants at risk
AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
|
Stage B/Vehicle
n=20 participants at risk
Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
|
|---|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
2.9%
1/35 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/15 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
7.5%
3/40 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/20 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
6.7%
1/15 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
25.0%
10/40 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
5.0%
1/20 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
5.7%
2/35 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/15 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
72.5%
29/40 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
15.0%
3/20 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/15 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
10.0%
4/40 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
10.0%
2/20 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/35 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
6.7%
1/15 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/20 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
6.7%
1/15 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
0.00%
0/40 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
5.0%
1/20 • Adverse events were collected for the duration of the study. This reporting group includes all subjects exposed to test article in Stage A and Stage B.
An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the subjects and as observations by the study Investigator.
|
Additional Information
Terri Pasquine, Clinical Project Lead
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER