Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-28 @ 4:46 PM
Study NCT ID:
NCT01476904
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2011-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study in Adolescent and Adult Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2016-02-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2011-11-15', 'dispFirstSubmitQcDate': '2016-02-11', 'studyFirstSubmitQcDate': '2011-11-18', 'dispFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'up to 12 weeks', 'description': 'Recording of all adverse events experienced during the course of the study'}], 'secondaryOutcomes': [{'measure': 'Change in 12 lead ECG including QT/QTc analysis', 'timeFrame': 'Study visit 4, 8 and 12, greater than one hour after last dose', 'description': 'A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.'}, {'measure': 'Asthma Exacerbations', 'timeFrame': 'up to 12 weeks', 'description': 'Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Bronchial Asthma', 'Shortness of breath'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '2019665', 'type': 'BACKGROUND', 'citation': 'Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7. doi: 10.1002/j.1552-4604.1991.tb04969.x.'}, {'pmid': '16400891', 'type': 'BACKGROUND', 'citation': 'Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4. doi: 10.1016/S1081-1206(10)61014-9.'}, {'pmid': '3780129', 'type': 'BACKGROUND', 'citation': 'Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.'}, {'pmid': '10919679', 'type': 'BACKGROUND', 'citation': 'Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.'}, {'pmid': '11061773', 'type': 'BACKGROUND', 'citation': 'Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.'}, {'pmid': '10936150', 'type': 'BACKGROUND', 'citation': 'Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6. doi: 10.1378/chest.118.2.522.'}, {'pmid': '9872837', 'type': 'BACKGROUND', 'citation': 'Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.'}, {'pmid': '31959019', 'type': 'DERIVED', 'citation': 'Kerwin EM, Tashkin DP, Korenblat PE, Greos LS, Pearlman DS, Bensch GW, Miller SD, Marrs T, Luo MZ, Zhang JY. Long-term safety and efficacy studies of epinephrine HFA metered-dose inhaler (Primatene(R) Mist): a two-stage randomized controlled trial. J Asthma. 2021 May;58(5):633-644. doi: 10.1080/02770903.2020.1713147. Epub 2020 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation\n* Male and female asthma patients aged 12 - 75 years\n* Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment\n* No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening\n* Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter\n* Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study\n\nExclusion Criteria:\n\n* A smoking history of 10-pack years, or having smoked within 12 months of screening\n* Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma\n* Concurrent clinically significant diseases\n* Known intolerance or hypersensitivity to any component of the study drugs\n* Recent infection of the respiratory tract, before screening\n* Use of prohibited medications\n* Having been on other investigational drug/device studies in the last 30 days prior to screening\n* Known or highly suspected substance abuse'}, 'identificationModule': {'nctId': 'NCT01476904', 'briefTitle': 'Safety Study in Adolescent and Adult Patients With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amphastar Pharmaceuticals, Inc.'}, 'officialTitle': 'A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)', 'orgStudyIdInfo': {'id': 'API-E004-CL-C2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm T', 'description': 'Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals', 'interventionNames': ['Drug: Epinephrine inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm P', 'description': 'Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals', 'interventionNames': ['Drug: Primatene Mist']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '0 mcg/inhalation, 2 inhalations QID', 'armGroupLabels': ['Arm P']}, {'name': 'Primatene Mist', 'type': 'DRUG', 'description': '220 mcg/inhalation, 2 inhalations QID', 'armGroupLabels': ['Arm A']}, {'name': 'Epinephrine inhalation', 'type': 'DRUG', 'description': '125 mcg/inhalation, 2 inhalations QID', 'armGroupLabels': ['Arm T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Site 0006', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Site 0005', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Site 0004', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Site 0001', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95207', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Site 0003', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amphastar Site 0008', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amphastar Site 0009', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '52240', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Amphastar Site 0011', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Amphastar Site 0013', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Amphastar Site 0014', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55441', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Amphastar Site 0015', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Amphastar Site 0016', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59718', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Amphastar Site 0017', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '68123', 'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Amphastar Site 0019', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'zip': '08558', 'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Amphastar Site 0020', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Amphastar Site 0018', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Amphastar Site 0021', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97520', 'city': 'Ashland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amphastar Site 0024', 'geoPoint': {'lat': 42.19458, 'lon': -122.70948}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amphastar Site 0022', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amphastar Site 0023', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amphastar Site 0025', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97202', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Amphastar Site 0026', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Amphastar Site 0029', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '79903', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Amphastar Site 0031', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '78130', 'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Amphastar Site 0030', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'zip': '23229', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Amphastar Site 0033', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Amphastar Site 0034', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Safety Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amphastar Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amphastar Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}