Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:31 PM
Study NCT ID:
NCT01465906
Status:
UNKNOWN
Last Update Posted:
2011-11-09
First Post:
2011-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
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': 'C010809', 'term': 'tulobuterol'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-10-28', 'studyFirstSubmitQcDate': '2011-11-02', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFT values (pulmonary function test, see description below)', 'timeFrame': '3 months', 'description': 'IC (inspiratory capacity) 、PEF (peak expiratory flow)、FVC (forced vital capacity)、FEV1 (forced expiratory volume in the first second)、%FEV1 (forced expiratory volume in the first second as predicted)、RV (residual volume)、TLC (total lung capacity)、RV/TLC% (residual volume/total lung capacity as percentage), etc.'}, {'measure': 'MRC （Medical Research Council） grade', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': "SGRQ （St. George's questionnaire） score", 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Phrase: IV\n\nIndication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)\n\nObjective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium bromide for relieving dyspnea symptom of COPD\n\nDesign: a multi-centre randomized parallel blank control study\n\nCase number: test group 80, control group 80, totally 160\n\nSite number:7\n\nStudy period: 2010.9 - 2011.8'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people aging from 40 to 80 with self ability of judgment\n* out-patients diagnosed as stable COPD according to "diagnosing and treatment guideline of COPD (2007 edition)" by Respiratory Department of Chinese Medical Association\n* PFT value at screen phase meet the standard as follows: FEV1/FVC \\< 70% and FEV1% among 30%-80% 15 mins after inhalation of 400ug Ventolin (i.e., moderate and severe COPD patients ).\n* people who can use Tiotropium Bromide powder inhalation device\n* people who join the study voluntarily and sign ICF (Informed Consent Form)\n\nExclusion Criteria:\n\n* people who have other acute or chronic respiratory diseases which may cause impairment of pulmonary function such as asthma\n* AECOPD （acute exacerbation of COPD）\n* people who got respiratory failure 1 month before the study\n* people who received oral corticoid treatment 1 month before the study\n* people who undergo oxygen therapy at home because of respiratory failure\n* people who are allergic to β2 receptor agonist such as tulobuterol\n* patients with Skin diseases such as atopic dermatitis, who are not appropriate to use transdermal patch\n* patients of hyperthyroidism, hypertension, heart disease and severe arrhythmia, diabetes mellitus, who are not appropriate to useβ2 receptor agonist\n* patients who have undergone pulmonary lobectomy or have tumor\n* active tuberculosis patients\n* people who got acute respiratory tract infection in a month or during screening phase\n* allergic rhinitis patients\n* glaucoma patients\n* people who have diseases which may cause dysuria such as prostatic hypertrophy or bladder neck occlusion\n* gestation, lactation and child-bearing age women who don\'t agree to take contraceptive measures during the study\n* people with abnormal live or kidney function, people with nervous system diseases, malignant tumor, neutropenia or other progressive basic diseases.\n* People who are mental retardation, mentally ill, deaf-mute or uncooperative, who cannot correctly describe their disease or do corresponding respiratory questionnaire.\n* People who are allergic to atropine and its derivatives (including tiotropium bromide and ipratropium bromide), lactose or any inhalant components.\n* people who have taken part in other medical clinical trial\n* other conditions that investigators think not appropriate for the study'}, 'identificationModule': {'nctId': 'NCT01465906', 'briefTitle': 'Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'orgStudyIdInfo': {'id': 'TG1015TLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tulobuterol combined with tiotropium bromide', 'interventionNames': ['Drug: tulobuterol', 'Drug: tiotropium bromide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tiotropium bromide', 'interventionNames': ['Drug: Tiotropium Bromide']}], 'interventions': [{'name': 'tulobuterol', 'type': 'DRUG', 'description': 'patch, 2mg, qN, 3 months', 'armGroupLabels': ['tulobuterol combined with tiotropium bromide']}, {'name': 'Tiotropium Bromide', 'type': 'DRUG', 'description': '18ug, inhale, qD, 3 months', 'armGroupLabels': ['Tiotropium bromide']}, {'name': 'tiotropium bromide', 'type': 'DRUG', 'description': '18ug, inhale, qD, 3 months', 'armGroupLabels': ['tulobuterol combined with tiotropium bromide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chunxue Bai, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Respiratory Department , Shanghai Zhongshan Hospita', 'investigatorFullName': 'Chunxue Bai', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}