Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-22 @ 10:52 AM
Study NCT ID:
NCT06731959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '4 weeks', 'description': 'Change from baseline in prebronchodilator FEV1 at Week 4'}], 'secondaryOutcomes': [{'measure': 'Incidence of AEs (including SAEs and AESIs) throughout the study', 'timeFrame': '4 weeks', 'description': 'Incidence of treatment related AEs (including SAEs and AESIs) throughout the study as assessed by CTCAE v4.0'}, {'measure': 'Change from baseline in CT mucus plug segment score at Week 4', 'timeFrame': '4 weeks', 'description': 'Change from baseline in CT mucus plug segment score (0-20) at Week 4'}, {'measure': 'Change from baseline in E-RS:COPD score at Week 4', 'timeFrame': '4 weeks', 'description': 'Change from baseline in E-RS:COPD score (0-40) at Week 4'}, {'measure': 'Change from baseline in prebronchodilator FVC at Week 4', 'timeFrame': '4 weeks', 'description': 'Change from baseline in prebronchodilator forced vital capacity (FVC) at Week 4'}, {'measure': 'Change from baseline in SpO2 at Week 4', 'timeFrame': '4 weeks', 'description': 'Change from baseline in oxygen saturation (SpO2) at Week 4'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.\n\nStudy will compare active drug to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria\n\nEach participant must meet all the following criteria to be enrolled in this study:\n\n* Participant is male or female ≥40 to ≤80 years of age.\n* Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is \\>25% and \\<60% of predicted normal at Visit 1.\n* Participant meets the following spirometry performance criteria:\n\n * Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2.\n * Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2.\n* Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.\n* Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.\n\nMain Exclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n* Participant has an active uncontrolled medical condition\n* Participant has a diagnosis of current asthma\n* Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.\n* Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1\n* Participant has active lung infection\n* Participant has received any vaccine within 7 days prior to Day 1.\n* Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.'}, 'identificationModule': {'nctId': 'NCT06731959', 'acronym': 'AER-01-002', 'briefTitle': 'A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aer Therapeutics'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER-01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'AER-01-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fexlamose', 'description': 'Fexlamose solution once daily via nebulizer for 28 days', 'interventionNames': ['Drug: Flexlamose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo solution once daily via nebulizer for 28 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Flexlamose', 'type': 'DRUG', 'description': 'Fexlamose solution via nebulizer for 28 days', 'armGroupLabels': ['Fexlamose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo solution via nebulizer for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jordan Low', 'role': 'CONTACT', 'email': 'jordan.low@aertherapeutics.com', 'phone': '4256239331'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aer Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}