Trial Outcomes & Findings for The Effect of N115 on Coughing in IPF Patients (NCT NCT06037408)
NCT ID: NCT06037408
Last Updated: 2024-08-07
Results Overview
Percent change in coughing was calculated by subtracting the baseline coughs per day from the day 21 coughs per day and then dividing by the baseline coughs per day. The a priori threshold was set at a 25% or greater decrease. (An episode is defined as 5 or more coughs per hour.)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
21 days
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
20mM Sodium Pyruvate Nasal Spray Treatment
20mM sodium pyruvate nasal spray: The product is a 20 mM (0.2%, 2.2 mg/mL) sodium pyruvate nasal spray in 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2 (N115). Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
Saline Placebo Control
Saline Placebo control nasal spray: The placebo is 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2. Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of N115 on Coughing in IPF Patients
Baseline characteristics by cohort
| Measure |
20mM Sodium Pyruvate Nasal Spray Treatment
n=26 Participants
20mM sodium pyruvate nasal spray: The product is a 20 mM (0.2%, 2.2 mg/mL) sodium pyruvate nasal spray in 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2 (N115). Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
Saline Placebo Control
n=24 Participants
Saline Placebo control nasal spray: The placebo is 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2. Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPercent change in coughing was calculated by subtracting the baseline coughs per day from the day 21 coughs per day and then dividing by the baseline coughs per day. The a priori threshold was set at a 25% or greater decrease. (An episode is defined as 5 or more coughs per hour.)
Outcome measures
| Measure |
20mM Sodium Pyruvate Nasal Spray Treatment
n=26 Participants
20mM sodium pyruvate nasal spray: The product is a 20 mM (0.2%, 2.2 mg/mL) sodium pyruvate nasal spray in 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2 (N115). Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
Saline Placebo Control
n=24 Participants
Saline Placebo control nasal spray: The placebo is 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2. Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
|---|---|---|
|
Percent Change in Coughing Episodes Per Day From Baseline to Day 21.
|
-73.2 % change in coughing episodes
Standard Deviation 8.1
|
-16.1 % change in coughing episodes
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 21 daysThe FEV1/FVC ratio was determined for baseline and day 21. The percent change was then calculated subtracting the baseline FEV1/FVC ratio from the day 21 FEV1/FVC ratio and then dividing by the baseline FEV1/FVC ratio. The a priori change was set at 12% or more.
Outcome measures
| Measure |
20mM Sodium Pyruvate Nasal Spray Treatment
n=26 Participants
20mM sodium pyruvate nasal spray: The product is a 20 mM (0.2%, 2.2 mg/mL) sodium pyruvate nasal spray in 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2 (N115). Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
Saline Placebo Control
n=24 Participants
Saline Placebo control nasal spray: The placebo is 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2. Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
|---|---|---|
|
Percent Change in FEV1/FVC Ratios From Baseline to Day 21.
|
27.9 % change in FEV1/FVC ratios
Standard Deviation 22.0
|
2.73 % change in FEV1/FVC ratios
Standard Deviation 5.34
|
Adverse Events
20mM Sodium Pyruvate Nasal Spray Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Saline Placebo Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
20mM Sodium Pyruvate Nasal Spray Treatment
n=26 participants at risk
20mM sodium pyruvate nasal spray: The product is a 20 mM (0.2%, 2.2 mg/mL) sodium pyruvate nasal spray in 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2 (N115). Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
Saline Placebo Control
n=24 participants at risk
Saline Placebo control nasal spray: The placebo is 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2. Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Irritation
|
15.4%
4/26 • Number of events 4 • Adverse events were collected over the four week study, including one week pre-study baseline.
|
0.00%
0/24 • Adverse events were collected over the four week study, including one week pre-study baseline.
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the four week study, including one week pre-study baseline.
|
0.00%
0/24 • Adverse events were collected over the four week study, including one week pre-study baseline.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Adverse events were collected over the four week study, including one week pre-study baseline.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the four week study, including one week pre-study baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place