Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 9:32 PM
Study NCT ID:
NCT05392192
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
Sponsor:
Organization:
Raw JSON
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Baseline was Day 1 prior to dosing for each treatment period.', 'description': '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.', 'unitOfMeasure': 'coughs per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADX-629', 'description': 'ADX-629 300mg administered orally BID for two weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered orally BID for two weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.57', 'groupId': 'OG000', 'lowerLimit': '-10.20', 'upperLimit': '-0.93'}, {'value': '6.39', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '10.75'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.', 'description': '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.', 'unitOfMeasure': 'coughs per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Awake Cough Frequency Per Hour for Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADX-629', 'description': 'ADX-629 300mg administered orally BID for two weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered orally BID for two weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.51', 'groupId': 'OG000', 'lowerLimit': '-19.78', 'upperLimit': '-3.24'}, {'value': '2.45', 'groupId': 'OG001', 'lowerLimit': '-5.65', 'upperLimit': '10.56'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.', 'description': '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.', 'unitOfMeasure': 'coughs per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADX-629', 'description': 'ADX-629 300mg administered orally BID for two weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administered orally BID for two weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.39', 'groupId': 'OG000', 'lowerLimit': '-14.80', 'upperLimit': '-3.99'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '-3.27', 'upperLimit': '7.32'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.', 'description': '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.', 'unitOfMeasure': 'coughs per hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ADX-629 First, Then Placebo', 'description': '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.'}, {'id': 'FG001', 'title': 'Placebo First, Then ADX-629', 'description': 'Placebo administered orally BID for two weeks, followed by a two-week washout, then ADX-629 300mg administered orally BID for two weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Fifty-one subjects were randomized in a crossover design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ADX-629 First, Then Placebo', 'description': 'ADX-629 300mg administered orally BID for two weeks, followed by a two-week washout, then placebo administered orally BID for two weeks.'}, {'id': 'BG001', 'title': 'Placebo First, Then ADX-629', 'description': 'Placebo administered orally BID for two weeks, followed by a two-week washout, then ADX-629 300mg administered orally BID for two weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '28.4', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '28.9', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-16', 'size': 787677, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-14T13:16', 'hasProtocol': True}, {'date': '2023-04-14', 'size': 3694312, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-14T14:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2022-05-05', 'resultsFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-24', 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Serious Adverse Events', 'timeFrame': 'The safety assessment period was Day 1 - Day 14 for each treatment period.', 'description': 'Safety was assessed through serious adverse event collection.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Awake Cough Frequency Per Hour With Prior Treatment as a Factor', 'timeFrame': 'The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.', 'description': '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.'}, {'measure': 'Change From Baseline in 24-hour Cough Frequency Per Hour With Prior Treatment as a Factor', 'timeFrame': 'The efficacy assessment period was Day 14 for each treatment period. Baseline was Day 1 prior to dosing for each treatment period.', 'description': '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.'}, {'measure': 'Change From Baseline in Awake Cough Frequency Per Hour for Period 1', 'timeFrame': 'The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.', 'description': '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.'}, {'measure': 'Change From Baseline in 24-hour Cough Frequency Per Hour for Period 1', 'timeFrame': 'The efficacy assessment period was Day 14. Baseline was Day 1 for Period 1.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refractory cough', 'cough hypersensitivity', 'ADX-629', 'unexplained cough', 'reactive aldehyde species', 'crossover', 'inflammation'], 'conditions': ['Chronic Cough']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 to ≤80 years of age\n* History of refractory or unexplained chronic cough\n* Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough\n* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable\n* Agree to discontinue antitussive medications for the trial duration\n\nExclusion Criteria:\n\n* Current smoker (including cannabis products) or previous smoker having recently given up smoking or has a history of smoking of \\>20 pack-years\n* History of significant cardiovascular disease or any clinically significant abnormalities in rhythm or conduction\n* History or presence of significant hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* History of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.\n* Recent history of drug or alcohol abuse or a positive urine drug test at screening\n* Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1 and HIV-2\n* Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI within 3 months of Screening.'}, 'identificationModule': {'nctId': 'NCT05392192', 'briefTitle': 'A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ADX-629-CC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADX-629', 'description': 'Subjects will be randomized to receive ADX-629 300mg tablets administered orally twice a day for 14 days.', 'interventionNames': ['Drug: ADX-629']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will be randomized to receive matching placebo tablets administered orally twice a day for 14 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ADX-629', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['ADX-629']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Allergy Associates Medical Group, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Asthma Associates of Santa Clara Valley Research Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Cano Research - 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