Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT02242227
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2014-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder Administered Via the HandiHaler® 2 and Serevent® Diskus® 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-16', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing'}], 'secondaryOutcomes': [{'measure': 'Change in peak FEV1', 'timeFrame': 'within 3 hours post-dosing', 'description': 'Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing'}, {'measure': 'Change in FEV1 AUC12-24h', 'timeFrame': '12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Change in FEV1 AUC0-24h', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Individual FEV1 measurements at each time point', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Change in forced vital capacity (FVC) AUC0-12h', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing'}, {'measure': 'Change in peak FVC', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Change in FVC AUC12-24h', 'timeFrame': '12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Change in FVC AUC0-24h', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Individual FVC measurements at each time point', 'timeFrame': 'Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 23 days'}, {'measure': 'AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2; a time interval from 0 - 8 h is appropriate)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'λz (terminal rate constant in plasma)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 't½ (terminal half-life of the analyte in plasma)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'MRTih (mean residence time of the analyte in the body after inhalational administration)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'CL/F (apparent clearance of the analyte in the plasma after extravascular administration)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)', 'timeFrame': 'pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration'}, {'measure': 'Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)', 'timeFrame': '0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration'}, {'measure': 'fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)', 'timeFrame': '0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration'}, {'measure': 'CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)', 'timeFrame': '0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial was to establish non-inferiority of lung function response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose inhalation in patients with COPD.\n\nThe secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions\n* All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:\n\n * Patients must have relatively stable\\* airway obstruction with a pre-dose FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC at Visits 1 and 2.\n\n * \\*The enrolment of patients who have had an exacerbation within six weeks prior to planned study entry should be postponed\n* At Visit 1, patients must demonstrate an improvement in FEV1 of ≥ 12% over the pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 μg salbutamol (Sultanol® MDI)\n* Male or female patients 40 years of age or older\n* Patients must be current or ex-smokers with a smoking history of more than 10 pack-years ((Patients who have never smoked cigarettes must be excluded)\n* Patients must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol\n* Patients must be able to inhale medication in a competent manner from the HandiHaler® 2 device and the Diskus® device\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 which may influence the results of the study or the patient's ability to participate in the study\n* Patients with a recent history (i.e., six months or less) of myocardial infarction\n* Patients who have been hospitalized for heart failure (New York Heart Association (NYHA) class III or IV) within the past year\n* Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year\n* Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed\n* Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥600/mm3\n* Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis\n* Patients with known active tuberculosis\n* Patients with significant alcohol or drug abuse within the past two years\n* Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1\n* Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study\n* Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy\n* Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions\n* Patients who have been treated with cromolyn sodium or nedocromil sodium within one month prior to Visit 1 or during the run-in period\n* Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day\n* Patients with known hypersensitivity to beta-adrenergics, lactose or any other components of the inhalation capsule delivery system or the Diskus®\n* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.: Norplant®)\n* Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Visit 1\n* Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1 or during the run-in period\n* Patients who have been treated with theophylline preparations within one month prior to Visit 1 or during the run-in period\n* Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within one month prior to Visit 1 or during the run-in period\n* Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period. In the case of a respiratory infection during the run-in period the latter may be extended up to six weeks\n* Patients who are currently participating in another study"}, 'identificationModule': {'nctId': 'NCT02242227', 'briefTitle': 'Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder Administered Via the HandiHaler® 2 and Serevent® Diskus® in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder (25 μg Salmeterol), Administered as the Xinafoate Salt From a Hard Polyethylene Capsule Via the HandiHaler® 2, and Serevent® Diskus® (50 μg Salmeterol) in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '1184.10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salmeterol xinafoate', 'description': '25 μg Salmeterol inhalation powder administered via HandiHaler®', 'interventionNames': ['Drug: Salmeterol xinafoate', 'Drug: Placebo (Diskus®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Serevent® Diskus®', 'description': '50 μg Salmeterol (dry powder inhaler) administered via Diskus®', 'interventionNames': ['Drug: Serevent® Diskus®', 'Drug: Placebo (HandiHaler®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo (HandiHaler®)', 'Drug: Placebo (Diskus®)']}], 'interventions': [{'name': 'Salmeterol xinafoate', 'type': 'DRUG', 'armGroupLabels': ['Salmeterol xinafoate']}, {'name': 'Serevent® Diskus®', 'type': 'DRUG', 'armGroupLabels': ['Serevent® Diskus®']}, {'name': 'Placebo (HandiHaler®)', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Serevent® Diskus®']}, {'name': 'Placebo (Diskus®)', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Salmeterol xinafoate']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}