Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-28 @ 7:48 AM
Study NCT ID:
NCT01426893
Status:
COMPLETED
Last Update Posted:
2012-03-29
First Post:
2011-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], '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'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2011-08-29', 'studyFirstSubmitQcDate': '2011-08-31', 'lastUpdatePostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Investigator's evaluation of the correctness of patients' usage of inhaler device in patients with asthma or COPD assesses by investigator/pulmonologist", 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': "Global assessment of disease control, done by investigator. Investigator will globally assess the disease control by one on three categories: 'fully controlled', 'partially controlled', 'uncontrolled'.", 'timeFrame': '12 weeks'}, {'measure': "Evaluation of patients' perception of the inhaler device and their perspective of symptom control and impact on daily life, by using the patient's questionnaire", 'timeFrame': '12 weeks'}, {'measure': 'Evaluation of the influence of practical education of the patients (performed by physician and/or nursing staff) on all above parameters/assessments', 'timeFrame': '12 weeks'}, {'measure': 'Collection of local demographics data in patients with asthma or COPD', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory disease', 'COPD'], 'conditions': ['Asthma,', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The correct use of inhalation devices is an inclusion criterion for all studies comparing inhaled treatments. In real life, however, patients may make many errors with their usual inhalation device, which may negate the benefits observed in clinical trials. In real life, many errors seem to be made, but no wide-scale evaluation has been performed. The correct use of inhalation devices is essential to ensure the effectiveness of the treatment. It has been recently demonstrated that inhaler misuse is associated with decreased asthma control in asthmatics treated with an inhaled corticosteroid. The aim of our observational study was to evaluate the inhaler device usage in patients with asthma or chronic obstructive pulmonary disease (COPD).', 'detailedDescription': 'Observational study to evaluate the correctness of the use of inhaler device in patients with asthma or chronic obstruct'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Speciality care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of subject informed consent\n* Females or males aged \\> 18 years\n\nExclusion Criteria:\n\n\\- If participating in any other clinical trial, the subject cannot take part in this study'}, 'identificationModule': {'nctId': 'NCT01426893', 'briefTitle': 'Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Observational Study to Evaluate the Correctness of the Use of Inhaler Device in Patients With Asthma or Chronic Obstruct', 'orgStudyIdInfo': {'id': 'NIS-RRS-XXX-2011/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The inhaler device usage in patients with asthma or COPD'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Kamenitz', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.22334, 'lon': 19.84263}}, {'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'city': 'Niš', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'city': 'Sombor', 'country': 'Serbia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.77417, 'lon': 19.11222}}], 'overallOfficials': [{'name': 'Predrag Rebic, Prof.dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Center of Serbia, Belgrade'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}