Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT02236169
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2014-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Determine the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to ATROVENT® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose', 'timeFrame': 'Up to 24 hours (h) after single drug administration'}, {'measure': 'Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state', 'timeFrame': '1h after drug administration'}, {'measure': 'Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state', 'timeFrame': 'up to 6 h after drug administration'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma ipratropium concentration time curve at different time points', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Peak plasma ipratropium concentration at different time points', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Trough plasma ipratropium concentration at different time points', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Time to peak plasma ipratropium concentrations at steady state', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Degree of fluctuation (DF) of the plasma ipratropium concentrations', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Area under the plasma ipratropium concentration time curve', 'timeFrame': 'Day 1 after first drug administration'}, {'measure': 'Peak plasma ipratropium concentration', 'timeFrame': 'Day 1 after first drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Changes from baseline in pulse rate and blood pressure', 'timeFrame': 'Baseline, day 23 day after first drug administration'}, {'measure': 'Number of patients with clinical significant findings in laboratory tests', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Number of patients with clinical significant findings in physical examination', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Number of patients with clinical significant findings in electrocardiogram (ECG)', 'timeFrame': 'Up to 23 days after first drug administration'}, {'measure': 'Changes from test-day baseline in pulse rate and blood pressure', 'timeFrame': 'Up to 23 days after first drug administration'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in COPD patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients must have a diagnosis of COPD and must meet the following spirometric criteria:\n\n* Patients must have a stable, moderate to severe airway obstruction with an Forced Expiratory Volume in one second (FEV1) \\<=65% of predicted normal and FEV1 \\<=70% of Forced vital capacity (FVC)\n\n * Males: Predicted Normal FEV1 = 0.093 (height in inches)-0.032 (age)-1.343\n * Females: Predicted Normal FEV1 = 0.085 (height in inches)-0.025(age)-1.692\n* Male or female age 40 years or older\n* Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes (20 cigarettes) per day for a year\n* Patients must be able to satisfactorily administer the medication, perform pulmonary function tests (PFTs) and maintain records during the study period as required in the protocol\n* All patients must sign an Informed Consent Form prior to participation in the trial (i.e., prior to pre-study washout of their usual pulmonary medications and prior to fasting for laboratory tests)\n\nExclusion Criteria:\n\n* Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease with may influence the results of the study or patients ability to participate in the study\n* Patients with clinically relevant baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion the patient is excluded\n* All patients with serum glutamic oxaloacetic transaminase (SGOT) \\>80 IU/L, serum glutamic pyruvic transaminase (SGPT) \\>80 IU/L, bilirubin \\>2.0 mg/dl, or creatinine \\>2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these patients\n* Patients with a history of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm3. A repeat eosinophil count will be not be conducted in these patients\n* Patients with a recent (i.e., one year or less) history of myocardial infarction\n* Patients with a recent history (i.e., three years or less) of cardiac failure, patients with cardiac arrhythmia requiring therapy, patients receiving any systemic beta-blockers and patients on chronic daytime oxygen therapy\n* Patients with known active tuberculosis\n* Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed\n* Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis\n* Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason should be evaluated per exclusion criterion No.1\n* Patients with an upper respiratory tract infection or COPD exacerbation in the 6 weeks prior to the screening visit (Visit 1) or during the baseline period\n* Patients with known hypersensitivity to anticholinergic drugs\n* Patients with known symptomatic prostatic hypertrophy or bladder-neck obstruction\n* Patients with known narrow-angle glaucoma\n* Patients who are on cromolyn sodium or nedocromil sodium\n* Patients who are on antihistamines\n* Pregnant or nursing women and women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)\n* Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in another research study\n* Patients with a history of and/or active alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT02236169', 'briefTitle': 'Trial to Determine the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to ATROVENT® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 µg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 µg ATROVENT® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '244.2480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ipratropium bromide', 'interventionNames': ['Drug: Ipratropium bromide HFA-134a inhalation aerosol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ATROVENT', 'interventionNames': ['Drug: Atrovent CFC inhalation aerosol']}], 'interventions': [{'name': 'Ipratropium bromide HFA-134a inhalation aerosol', 'type': 'DRUG', 'armGroupLabels': ['Ipratropium bromide']}, {'name': 'Atrovent CFC inhalation aerosol', 'type': 'DRUG', 'armGroupLabels': ['ATROVENT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}