Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough (NCT NCT05392192)

NCT ID: NCT05392192

Last Updated: 2025-02-28

Results Overview

Safety was assessed through serious adverse event collection.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

The safety assessment period was Day 1 - Day 14 for each treatment period.

Results posted on

2025-02-28

Participant Flow

Fifty-one subjects were randomized in a crossover design.

Participant milestones

Participant milestones
Measure	ADX-629 First, Then Placebo ADX-629 300mg (milligrams) administered orally twice daily (BID) for two weeks, followed by a two-week washout, then placebo administered orally BID for two weeks.	Placebo First, Then ADX-629 Placebo administered orally BID for two weeks, followed by a two-week washout, then ADX-629 300mg administered orally BID for two weeks.
Overall Study STARTED	26	25
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADX-629 First, Then Placebo n=26 Participants ADX-629 300mg administered orally BID for two weeks, followed by a two-week washout, then placebo administered orally BID for two weeks.	Placebo First, Then ADX-629 n=25 Participants Placebo administered orally BID for two weeks, followed by a two-week washout, then ADX-629 300mg administered orally BID for two weeks.	Total n=51 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 9.5 • n=5 Participants	65.2 years STANDARD_DEVIATION 7.1 • n=7 Participants	65.3 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	29.4 kg/m2 STANDARD_DEVIATION 9.5 • n=5 Participants	28.4 kg/m2 STANDARD_DEVIATION 4.7 • n=7 Participants	28.9 kg/m2 STANDARD_DEVIATION 7.4 • n=5 Participants

PRIMARY outcome

Timeframe: The safety assessment period was Day 1 - Day 14 for each treatment period.

Population: Safety population

Safety was assessed through serious adverse event collection.

Outcome measures

Outcome measures
Measure	ADX-629 n=47 Participants ADX-629 300mg administered orally BID for 14 days.	Placebo n=51 Participants Placebo administered orally BID for 14 days.
Number of Subjects With Serious Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.

Population: Intent-to-treat population

Change from baseline in cough count was assessed while subjects were awake using a cough monitor with a digital recording device. The number of coughs is proportional to disease severity. Estimates were obtained using mixed model repeated measures (MMRM) analysis with treatment and prior treatment (none for Period 1; Period 1 treatment for Period 2) as fixed effects, and period-specific baseline as a covariate.

Outcome measures

Outcome measures
Measure	ADX-629 n=47 Participants ADX-629 300mg administered orally BID for 14 days.	Placebo n=51 Participants Placebo administered orally BID for 14 days.
Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor	-7.06 coughs per hour Interval -14.44 to 0.31	7.68 coughs per hour Interval 0.78 to 14.58

SECONDARY outcome

Timeframe: The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.

Population: Intent-to-treat population

Change from baseline in cough count was assessed for twenty-four hours using a cough monitor with a digital recording device. Number of coughs is associated with disease severity. Estimates were obtained using MMRM analysis with treatment and prior treatment (none for Period 1; Period 1 treatment for Period 2) as fixed effects, and period-specific baseline as a covariate.

Outcome measures

Outcome measures
Measure	ADX-629 n=47 Participants ADX-629 300mg administered orally BID for 14 days.	Placebo n=51 Participants Placebo administered orally BID for 14 days.
Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor	-5.57 coughs per hour Interval -10.2 to -0.93	6.39 coughs per hour Interval 2.04 to 10.75

SECONDARY outcome

Timeframe: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.

Population: Intent-to-treat population

Change from baseline in cough count in Period 1 was assessed while subjects were awake using a cough monitor with a digital recording device. The number of coughs is proportional to disease severity. Estimates were obtained using MMRM analysis with treatment as fixed effect, and Period 1-specific baseline as a covariate.

Outcome measures

Outcome measures
Measure	ADX-629 n=24 Participants ADX-629 300mg administered orally BID for 14 days.	Placebo n=25 Participants Placebo administered orally BID for 14 days.
Change From Baseline in Awake Cough Frequency Per Hour for Period 1	-11.51 coughs per hour Interval -19.78 to -3.24	2.45 coughs per hour Interval -5.65 to 10.56

SECONDARY outcome

Timeframe: The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.

Population: Intent-to-treat population

Change from baseline in cough count in Period 1 was assessed for twenty-four hours using a cough monitor with a digital recording device. The number of coughs is proportional to disease severity. Estimates were obtained using MMRM analysis with treatment as fixed effect, and Period 1-specific baseline as a covariate.

Outcome measures

Outcome measures
Measure	ADX-629 n=24 Participants ADX-629 300mg administered orally BID for 14 days.	Placebo n=25 Participants Placebo administered orally BID for 14 days.
Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1	-9.39 coughs per hour Interval -14.8 to -3.99	2.02 coughs per hour Interval -3.27 to 7.32

Adverse Events

ADX-629

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ADX-629 n=51 participants at risk ADX-629 300mg administered orally BID for 14 days.	Placebo n=51 participants at risk Placebo administered orally BID for 14 days.
Nervous system disorders Headache	5.9% 3/51 • Number of events 3 • Fourteen days for each intervention	0.00% 0/51 • Fourteen days for each intervention

Additional Information

Director of Clinical Trials

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place