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A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Chronic Cough
A Phase 2, multicenter, randomized, double-blind, placebo controlled, two-period crossover trial to evaluate the safety, tolerability, and efficacy of ADX-629 (300 mg) administered orally, twice-a-day to eligible participants with refractory or unexplained chronic cough. Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-629 | Experimental | Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days. |
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| Placebo | Placebo Comparator | Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-629 | Drug | Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serious Adverse Events | Safety was assessed through serious adverse event collection. | The safety assessment period was Day 1 - Day 14 for each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy Associates Medical Group, Inc. | San Diego | California | 92108 | United States | ||
| Allergy & Asthma Associates of Santa Clara Valley Research Center |
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Fifty-one subjects were randomized in a crossover design.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo First, Then ADX-629 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2022 | Jan 14, 2025 |
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| Placebo | Drug | Subjects will be randomized to receive both ADX-629 and placebo in one of two treatment sequences: One group of subjects will receive ADX-629 during the 1st treatment period and matching placebo during the 2nd Treatment while subjects the other sequence/group will receive the matching placebo in the 1st treatment period and ADX-629 in the 2nd treatment period. |
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| The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period. |
| Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor | 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. | The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period. |
| Change From Baseline in Awake Cough Frequency Per Hour for Period 1 | 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. | The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1. |
| Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1 | 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. | The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1. |
| San Jose |
| California |
| 95117 |
| United States |
| Cano Research - Hollywood | Hollywood | Florida | 33024 | United States |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | United States |
| Florida Pulmonary Research Institute LLC | Winter Park | Florida | 32789 | United States |
| ClinCept | Columbus | Georgia | 31904 | United States |
| Mayo Clinic Pulmonary Clinic Research Unit | Rochester | Minnesota | 55901 | United States |
| Mount Sinai | New York | New York | 10003 | United States |
| Charlotte Lung & Health/American Health Research | Charlotte | North Carolina | 28277 | United States |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45236 | United States |
| Vital Prospects Clinical Research | Tulsa | Oklahoma | 74136 | United States |
| Northwest Research Center | Portland | Oregon | 97202 | United States |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | United States |
| Pharmaceutical Research and Consulting Inc. | Dallas | Texas | 72531 | United States |
Placebo administered orally BID for two weeks, followed by a two-week washout, then ADX-629 300mg administered orally BID for two weeks.
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| NOT COMPLETED |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | ADX-629 First, Then Placebo | ADX-629 300mg administered orally BID for two weeks, followed by a two-week washout, then placebo administered orally BID for two weeks. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Serious Adverse Events | Safety was assessed through serious adverse event collection. | Safety population | Posted | Count of Participants | Participants | The safety assessment period was Day 1 - Day 14 for each treatment period. |
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| Secondary | Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor | 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. | Intent-to-treat population | Posted | Least Squares Mean | 95% Confidence Interval | coughs per hour | The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period. |
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| Secondary | Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor | 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. | Intent-to-treat population | Posted | Least Squares Mean | 95% Confidence Interval | coughs per hour | The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period. |
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| Secondary | Change From Baseline in Awake Cough Frequency Per Hour for Period 1 | 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. | Intent-to-treat population | Posted | Least Squares Mean | 95% Confidence Interval | coughs per hour | The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1. |
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| Secondary | Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1 | 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. | Intent-to-treat population | Posted | Least Squares Mean | 95% Confidence Interval | coughs per hour | The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1. |
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Fourteen days for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADX-629 | ADX-629 300mg administered orally BID for 14 days. | 0 | 51 | 0 | 51 | 3 | 51 |
| EG001 | Placebo | Placebo administered orally BID for 14 days. | 0 | 51 | 0 | 51 | 0 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2023 | Jan 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D003371 | Cough |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000716647 | ADX-629 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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