Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 6:34 PM
Study NCT ID:
NCT01174732
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2010-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001986', 'term': 'Bronchial Spasm'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2017-04-17', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2010-07-29', 'dispFirstSubmitQcDate': '2017-04-17', 'studyFirstSubmitQcDate': '2010-08-02', 'dispFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.', 'description': 'Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control.'}], 'secondaryOutcomes': [{'measure': 'Time to Effect', 'timeFrame': '0 to 360 minutes', 'description': 'Time to onset of bronchodilator effect'}, {'measure': 'Peak Response', 'timeFrame': '0 - 360 minutes', 'description': 'peak bronchodilator response'}, {'measure': 'Duration', 'timeFrame': '0 - 360 minutes', 'description': 'Duration of effect'}, {'measure': 'Response Rate', 'timeFrame': '0 - 360 minutes', 'description': 'Bronchodilatory Response Rate'}, {'measure': 'Hand Tremor', 'timeFrame': 'within 5 min. prior to dosing and 50 and 360 min post-dose.', 'description': 'Evaluation of hand tremor'}, {'measure': 'Vital Signs', 'timeFrame': 'within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.', 'description': 'Pulse, heartrate, respirations, blood pressure'}, {'measure': '12 lead ECG', 'timeFrame': 'within 15 min. prior to dosing and at 50 and 360 min postdose.', 'description': '12-lead ECG for routine and QT/QTc evaluations'}, {'measure': 'Blood Work', 'timeFrame': 'within 15 min. prior to dosing, and 30 and 120 min. postdose', 'description': 'Collect blood samples (\\~5 mL) for serum glucose and K+ tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'bronchospasm', 'COPD', 'chronic respiratory disease'], 'conditions': ['Asthma', 'Bronchospasm']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;\n* Must demonstrate response to beta 2 agonist by Reversing;\n* Must demonstrate ability to use DPI;\n* Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;\n* Additional Criteria\n\nExclusion Criteria:\n\n* Smoking history of ≥ 10 pack-years, or having smoked within 6 months;\n* Upper respiratory tract infections\n* Asthma exacerbations;\n* Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;\n* Use of prohibited drugs or failure to observe the drug washout restrictions;\n* Having been on other clinical drug/device studies in the last 30 days;\n* Other Criteria'}, 'identificationModule': {'nctId': 'NCT01174732', 'briefTitle': 'Dose-Ranging Study of A006 DPI, in Adult Asthma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amphastar Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients', 'orgStudyIdInfo': {'id': 'API-A006-CL-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T1', 'description': 'A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation', 'interventionNames': ['Drug: albuterol inhalation powder']}, {'type': 'EXPERIMENTAL', 'label': 'T2', 'description': 'A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation', 'interventionNames': ['Drug: albuterol inhalation powder']}, {'type': 'EXPERIMENTAL', 'label': 'T3', 'description': 'A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations', 'interventionNames': ['Drug: albuterol inhalation powder']}, {'type': 'EXPERIMENTAL', 'label': 'T4', 'description': 'A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations', 'interventionNames': ['Drug: albuterol inhalation powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'description': 'Placebo, 2 inhalations', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R1', 'description': 'Proventil 90 mcg/inhalation, 2 inhalations', 'interventionNames': ['Drug: albuterol inhalation aerosol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R2', 'description': 'Proventil 90 mcg/inhalation, 4 inhalations', 'interventionNames': ['Drug: albuterol inhalation aerosol']}], 'interventions': [{'name': 'albuterol inhalation powder', 'type': 'DRUG', 'description': 'A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation', 'armGroupLabels': ['T1']}, {'name': 'albuterol inhalation powder', 'type': 'DRUG', 'description': 'A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation', 'armGroupLabels': ['T2']}, {'name': 'albuterol inhalation powder', 'type': 'DRUG', 'description': 'A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations', 'armGroupLabels': ['T3']}, {'name': 'albuterol inhalation powder', 'type': 'DRUG', 'description': 'A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations', 'armGroupLabels': ['T4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo, lactose inhalation carrier', 'armGroupLabels': ['P']}, {'name': 'albuterol inhalation aerosol', 'type': 'DRUG', 'otherNames': ['Proventil'], 'description': 'albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations', 'armGroupLabels': ['R1']}, {'name': 'albuterol inhalation aerosol', 'type': 'DRUG', 'otherNames': ['Proventil'], 'description': 'albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations', 'armGroupLabels': ['R2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Site 0001', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amphastar Site 0007', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amphastar Site 0008', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80401', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Amphastar Site 0039', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}], 'overallOfficials': [{'name': 'Safety Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amphastar Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amphastar Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}