Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 11:29 PM
Study NCT ID:
NCT03275935
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2017-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080445', 'term': 'Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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': '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2017-09-06', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in \'Inhalation Scores" After a month from Baseline', 'timeFrame': 'After a month', 'description': 'An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7. After assessment, instructions were given with demonstrations regarding the correct use of Rotahaler. One month later (post-training visit), all patients were re-evaluated'}], 'secondaryOutcomes': [{'measure': 'Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.', 'timeFrame': '3 months', 'description': 'Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital'}, {'measure': 'Associated Factors for Incorrect Inhalation Technique', 'timeFrame': '3 months', 'description': 'The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis'}, {'measure': 'Prevalence of patients using the inhalation devices via incorrect technique', 'timeFrame': 'At pretraining', 'description': 'An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACOS', 'Asthma', 'COPD', 'inhalation technique'], 'conditions': ['COPD Asthma', 'Asthma-COPD Overlap Syndrome', 'Inhalation']}, 'descriptionModule': {'briefSummary': 'This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.', 'detailedDescription': 'This is a one group pretest- posttest design conducted in all patients presenting in Chest clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May 2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were included. Enrolled patients are assessed for inhalation technique compliance at their routine medical (pre-training) visits by physician. The use of inhaler device is evaluated in a practical manner by asking the patients to demonstrate their inhalation technique. After the assessment, instructions and training are given until they can use the device correctly. One month later (post-training), all patients are re-evaluated in regards to inhalation technique and subjective improvement of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to Chest Clinic of Dhulikhel hospital, who were diagnosed of having either COPD, Asthma or Asthma-COPD Overlap Syndrome and are currently under inhalational bronchodilators in the form of Dry Powder Device (DPIs)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years,\n* Diagnosed of having of asthma or COPD or ACOS\n* Using dry powder inhaler therapy with Rotahaler\n\nExclusion Criteria:\n\n* Use of inhaler devices other than Rotahaler\n* Newly started on dry powdered inhalational therapy or patients who had recently received face-to-face training program on inhalation technique within the past one month\n* Patients in acute exacerbation\n* Patients failing to give consent'}, 'identificationModule': {'nctId': 'NCT03275935', 'briefTitle': 'Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)', 'organization': {'class': 'OTHER', 'fullName': 'Kathmandu University School of Medical Sciences'}, 'officialTitle': 'Evaluation of Inhalation Technique in Patients With Chronic Obstructive Pulmonary Disease (COPD), Asthma or Asthma-COPD Overlap Syndrome(ACOS) Using a Dry Powder Device at Chest Clinic in Dhulikhel Hospital', 'orgStudyIdInfo': {'id': '73/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training Arm', 'description': 'Patients that were given training in regards to proper inhalation technique of Rotahalers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhulikhel', 'country': 'Nepal', 'facility': 'Dhulikhel Hospital- Kathmandu University Hospital', 'geoPoint': {'lat': 27.6221, 'lon': 85.54281}}], 'overallOfficials': [{'name': 'Dr Sudeep Shrestha, MD, MRCP(UK)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dhulikhel Hospital- Kathmandu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kathmandu University School of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, CardioPulmonology Unit, Department of Internal Medicine', 'investigatorFullName': 'Dr Sudeep Shrestha', 'investigatorAffiliation': 'Kathmandu University School of Medical Sciences'}}}}