Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-05 @ 3:32 AM
Study NCT ID:
NCT02109406
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With 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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2014-07-15', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2014-04-02', 'dispFirstSubmitQcDate': '2014-07-16', 'studyFirstSubmitQcDate': '2014-04-04', 'dispFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Day 1 through Day 15', 'description': 'Cmax, AUC0-12, AUC0-t, tmax, Apparent elimination half-life (t1/2), Apparent volume of distribution (Vd/F), Apparent total body clearance (CL/F)'}, {'measure': 'Safety', 'timeFrame': 'Day1 through Day 15', 'description': 'Safety will be assessed by adverse events (AEs), physical examination findings, dry mouth and tremor assessments, paradoxical bronchospasm, vital signs, electrocardiogram (ECG), and laboratory assessments.'}], 'primaryOutcomes': [{'measure': 'Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline', 'timeFrame': '14 Days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in morning pre dose trough FEV1', 'timeFrame': '14 Days'}, {'measure': 'Peak change in FEV1', 'timeFrame': '14 Days'}, {'measure': 'Forced vital capacity (FVC) AUC0-12 relative to baseline', 'timeFrame': '14 Days'}, {'measure': 'Peak change in FEV1', 'timeFrame': 'Day 1'}, {'measure': 'Change from baseline in 12-hour post dose trough FEV1', 'timeFrame': '14 Days'}, {'measure': 'Time to onset of action', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.\n* Current or former smokers with a history of ≥10 pack years of cigarette smoking.\n* Post-bronchodilator FEV1/FVC ratio of \\<70%.\n* Pre-bronchodilator FEV1 must be \\<80% predicted\n* Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.\n\nExclusion Criteria:\n\n* Pregnancy: Women who are pregnant or lactating.\n* Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.\n* Primary diagnosis of asthma.\n* Alpha-1 antitrypsin deficiency as the cause of COPD\n* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.\n* Poorly controlled COPD (hospitalization due to poorly controlled COPD within 3 months of Screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening or during Screening.\n* Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of Randomization.\n* Clinically significant abnormal ECG."}, 'identificationModule': {'nctId': 'NCT02109406', 'briefTitle': 'Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD', 'orgStudyIdInfo': {'id': 'AZD2115 D3060C00006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD2115 Dose 1', 'description': 'AZD 2115, Dose 1 administered as two inhalations BID', 'interventionNames': ['Drug: AZD2115 Dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'AZD 2115 Dose 2', 'description': 'AZD 2115, Dose 2 administered as two inhalations BID', 'interventionNames': ['Drug: AZD 2115, Dose 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI', 'description': 'Placebo MDI administered as two inhalations BID', 'interventionNames': ['Drug: Placebo MDI']}], 'interventions': [{'name': 'AZD2115 Dose 1', 'type': 'DRUG', 'description': 'AZD 2115, Dose 1 administered as two inhalations BID', 'armGroupLabels': ['AZD2115 Dose 1']}, {'name': 'AZD 2115, Dose 2', 'type': 'DRUG', 'description': 'AZD 2115, Dose 2 administered as two inhalations BID', 'armGroupLabels': ['AZD 2115 Dose 2']}, {'name': 'Placebo MDI', 'type': 'DRUG', 'description': 'Placebo MDI administered as two inhalations BID', 'armGroupLabels': ['Placebo MDI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Pearl Therapeutics Study Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pearl Therapeutics Study Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pearl Therapeutics Study Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}], 'overallOfficials': [{'name': 'Shahid Siddiqui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pearl Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearl Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}