Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00130351
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2005-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2005-08-08', 'studyFirstSubmitQcDate': '2005-08-12', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.'}, {'measure': 'Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.'}]}, 'conditionsModule': {'keywords': ['asthma, formoterol multi-dose dry powder inhaler (MDDPI)'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary\n* Patients who have a current diagnosis of asthma\n* Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a \\>12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.\n\nExclusion Criteria:\n\n* Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device.\n* QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study\n* Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies\n* Other protocol-defined inclusion and exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT00130351', 'briefTitle': 'A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma', 'orgStudyIdInfo': {'id': 'CFOR258F2309'}}, 'armsInterventionsModule': {'interventions': [{'name': 'formoterol', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Specialists Medical Group and Research Ct', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Medical Group & Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Asthma Associates of Santa Clara Res. Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Allergy and Asthma Centers, PC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80112', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Allergy and Asthma Centers, PC', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Northeast Medical Research Associates, Inc.', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Northeast Medical Research Associates, Inc', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Clinical Research Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68046', 'city': 'Papillion', 'state': 'Nebraska', 'country': 'United States', 'facility': 'The Asthma & Allergy Center, PC', 'geoPoint': {'lat': 41.15444, 'lon': -96.04224}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Clinical Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Allergy Associates Research Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}]}}}