Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-29 @ 11:08 PM
Study NCT ID:
NCT01092403
Status:
COMPLETED
Last Update Posted:
2012-01-26
First Post:
2010-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Clinical Activity of ASM-024 in Subjects With Mild Allergic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603639', 'term': 'ASM-024'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-25', 'studyFirstSubmitDate': '2010-03-23', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late asthmatic response (LAR)', 'timeFrame': 'Day 8 of each treatment period', 'description': 'LAR as measured by the peak drop in FEV1 from 3 to 7 hours post-allergen challenge'}, {'measure': 'Early asthmatic response (EAR)', 'timeFrame': 'Day 8 of every treatment period', 'description': 'EAR as measured by the peak drop in FEV1 from 0 to 3 hours post-allergen challenge'}, {'measure': 'Airway hyperresponsiveness', 'timeFrame': 'Days -1, 7 and 9 of each treatment period', 'description': 'Difference between methacholine PC20 measured 24 hours following allergen challenge and methacholine PC20 measured 24 hours before allergen challenge'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Physical examination: Day 9, vital signs: Days -1, 1, 7, 8 and 9; twelve-lead ECG: Days 1, 7, 8 and 9 , AEs throughout the study, safety laboratory assessments Day 1 and 9 and Chest X-Ray: Day 9 of the final treatment period'}], 'secondaryOutcomes': [{'measure': "LAR's FEV1 AUC", 'timeFrame': 'Day 8 of every treatment period', 'description': 'From 3 to 7 hours post-allergen challenge'}, {'measure': 'FEV1', 'timeFrame': 'Day 9', 'description': '24 hours post-allergen challenge'}, {'measure': "EAR's FEV1 AUC", 'timeFrame': 'Day 8', 'description': 'From 0 to 3 hours post-allergen challenge'}, {'measure': 'Change in FEV1', 'timeFrame': 'Days 1, 7, 8 and 9', 'description': 'Before inhalation of ASM-024 and as soon as possible following inhalation of ASM-024'}, {'measure': 'Induced sputum eosinophil count and eosinophil and neutrophil percentages', 'timeFrame': 'Days -1, 7 and 9 of every Treatment Period'}, {'measure': 'Blood eosinophil count', 'timeFrame': 'Days -1 and 9 of every Treatment Period'}, {'measure': 'Total and differential WBC count', 'timeFrame': 'Days -1 and 9 of every Treatment Period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Allergic Asthma']}, 'descriptionModule': {'briefSummary': 'The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects with mild allergic asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to provide written informed consent;\n* Male or female subjects, ≥18 years and ≤ 50 years of age;\n* Female subjects of childbearing potential must have a negative pregnancy test (serum b-HCG) at Pre-Screening, and a negative urine pregnancy test immediately before the first administration of the study drug for each of the three Treatment Periods. Sexually active females must be willing to use adequate contraception.\n* Male subjects must be willing to use a condom with a spermicide for the duration of their participation in the study, plus an additional 30 days following study drug administration and ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or a IUD. Male subjects must ensure that their female partner is willing to use adequate contraception;\n* Diagnosis of mild allergic asthma that meets the following criteria:\n\n * Stable on inhaled short-acting beta-2-agonists p.r.n. as the only medication for asthma.\n * Presence of both early asthmatic response (EAR) (at least 20 % fall in FEV1 within 3 hours after allergen inhalation) and late asthmatic response (LAR) (at least 15 % fall in FEV1).\n * Baseline methacholine (PC20) ≤ 16 mg/mL.\n* FEV1 of at least 70 % of the predicted value at Pre-Screening and Screening / Baseline;\n* BMI ≥ 19 and ≤ 35 kg/m²;\n* Body weight ≥ 40 kg;\n* Positive skin prick test to at least one common aeroallergen.\n\nExclusion Criteria:\n\n* Any lung disease other than mild allergic asthma;\n* Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Pre-Screening or a positive urine pregnancy test during the study;\n* Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence or a partner who has undergone a vasectomy;\n* Respiratory tract infections or worsening of asthma within 6 weeks before Screening/Baseline;\n* Baseline methacholine PC20 \\> 16 mg/mL at Screening / Baseline;\n* Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within the 12 months preceding enrolment in the study;\n* Use of any nicotine containing products within 6 months before Pre-Screening;\n* Any of the following concomitant medications:\n\n * Any medication that are known to prolong QT / QTc interval.\n * Oral or inhaled corticosteroids within 28 days preceding Pre-Screening or systemic corticosteroids within 90 days of Pre-Screening.\n * Long acting beta-2-agonists within one week preceding Baseline.\n * Use of inhaled short-acting β2- agonists or anticholinergics within 8 hours before all study visits to the clinic.\n* Known or suspected allergy or sensitivity to nicotine or cholinergic drugs or any drug with similar chemical structure;\n* Clinically significant ECG abnormalities at Pre-Screening including clinically significant or marked baseline prolongation of QT / QTc interval (e.g. repeated demonstration of a QTc interval of \\> 450 ms). Other non clinically significant findings such as sinus bradycardia, sinus arrhythmia, borderline first degree AV block (up to 205 ms), left ventricular hypertrophy (on voltage criteria for a subject less than 40 years old for instance) are permissible if judged to be acceptable by the Qualified investigator;\n* Family history of additional risk factors for TdP (e.g., family history of Long QT Syndrome.'}, 'identificationModule': {'nctId': 'NCT01092403', 'briefTitle': 'Safety, Tolerability and Clinical Activity of ASM-024 in Subjects With Mild Allergic Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asmacure Ltée'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of ASM-024 Administered by Inhalation Once Daily to Subjects With Mild Allergic Asthma', 'orgStudyIdInfo': {'id': 'ASM-024/II/STA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASM-024', 'description': 'ASM-024 once daily by inhalation', 'interventionNames': ['Drug: ASM-024']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily by inhalation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASM-024', 'type': 'DRUG', 'description': 'ASM-024 50 mg of ASM-024 or 200 mg once daily by inhalation', 'armGroupLabels': ['ASM-024']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily by inhalation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Mc Master University Health Sciences Center'}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche - Institut universitaire de cardiologie et de pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatechewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Louis-Philippe Boulet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asmacure Ltée', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}