Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04349735
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of 3 Methods to Assess Inhalation Technique
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'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'comparison of three methods of assessment of inhaltion technique'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of reliability of assessment of inhalation technique by checklist method in patients with asthma and COPD', 'timeFrame': 'baseline', 'description': 'Assessment of reliability of checklist method measured by 2 observers by kappa Cohen coefficient'}, {'measure': 'Comparison of reliability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD', 'timeFrame': 'baseline', 'description': 'Assessment of reliability of 4 grade scale measured by 2 observers by kappa Cohen coefficient'}, {'measure': 'Comparison of validity of assessment of inhalation technique by checklist method in patients with asthma and COPD', 'timeFrame': 'baseline', 'description': 'Assessment of validity of checklist method measured by convergence between observer and an expert baseline by kappa Cohen coefficient'}, {'measure': 'Comparison of validity of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD', 'timeFrame': 'baseline', 'description': 'Assessment of validity of 4 grade scale measured by convergence between observer and an expert baseline by kappa Cohen coefficient'}, {'measure': 'Comparison of validity of assessment of inhalation technique by Vitalograph®AIM in patients with asthma and COPD', 'timeFrame': '30 minutes from baseline', 'description': 'Assessment of validity of Vitalograph®AIM method (convergence between assessment of Vitalograph®AIM and an expert)'}], 'secondaryOutcomes': [{'measure': 'Utility of Vitalograph® AIM in inhalation technique training', 'timeFrame': 'baseline and in 30 minutes', 'description': 'Difference in number of inhalation mistakes before and after Vitalograph® AIM based training'}, {'measure': 'Comparison of repeatability of assessment of inhalation technique by checklist method in patients with asthma and COPD', 'timeFrame': 'baseline and in 30 minutes', 'description': 'Assessment of reliability of checklist method measured by 1 observer baseline and in 30 minutes by kappa Cohen coefficient'}, {'measure': 'Comparison of repeatability of assessment of inhalation technique by 4 grade scale in patients with asthma and COPD', 'timeFrame': 'baseline and in 30 minutes', 'description': 'Assessment of reliability of 4 grade scale measured by 1 observer baseline and in 30 minutes by kappa Cohen coefficient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inhalation technique'], 'conditions': ['Asthma', 'COPD']}, 'referencesModule': {'references': [{'pmid': '29338792', 'type': 'BACKGROUND', 'citation': 'Usmani OS, Lavorini F, Marshall J, Dunlop WCN, Heron L, Farrington E, Dekhuijzen R. Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes. Respir Res. 2018 Jan 16;19(1):10. doi: 10.1186/s12931-017-0710-y.'}, {'pmid': '21310878', 'type': 'RESULT', 'citation': 'Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, Chrystyn H; European Respiratory Society; International Society for Aerosols in Medicine. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J. 2011 Jun;37(6):1308-31. doi: 10.1183/09031936.00166410. Epub 2011 Feb 10.'}, {'pmid': '21367593', 'type': 'RESULT', 'citation': 'Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2.'}, {'pmid': '27060726', 'type': 'RESULT', 'citation': 'Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'A significant percentage of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however none of them is recommended as the most accurate.\n\nTherefore, the aim of the study is:\n\n1. to compare three different methods of assessment of inhalation technique in patients with asthma and COPD.\n\n These methods include:\n 1. Checklist of mistakes in inhalation technique (including critical mistakes)\n 2. 4 grade scale of inhalation technique\n 3. Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)\n2. to analyze the influence of Vitalograph®AIM based inhalation technique training on inhalation skills\n\nOne hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. Additionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.', 'detailedDescription': "Asthma and chronic obstructive pulmonary disease (COPD) are common respiratory diseases. Inhaled therapy is the cornerstone of treatment in these two diseases. However, a significant proportion of patients with asthma and COPD do not use their inhalers properly. Experts recommend that in patients with obstructive lung diseases, inhalation technique and patient adherence should be evaluated at every visit, particularly before introducing changes to the patient's inhalation therapy. The assessment of inhalation skills depends on the method of evaluation. There are few different methods of assessment of inhalation technique, however, none of these methods is recommended as the most accurate.\n\nTherefore, the aim of the study is:\n\n1. to compare three different methods of assessment of inhalation technique in patients with asthma and COPD.\n\n These methods include:\n 1. Checklist of mistakes in inhalation technique (including critical mistakes)\n 2. 4 grade scale of inhalation technique\n 3. Assessment by Vitalograph®AIM (Aerosol Inhaling Monitor)\n2. to analyze an influence of using Vitalograph®AIM based inhalation technique training on inhalation skills.\n\nType of study: prospective, interventional, without randomization. Patients with asthma or COPD treated in hospital or in an out-patient clinic will be asked to participate in the study.\n\nStudy design One hundred and thirty patients with asthma or COPD, who use inhaled medication on a regular basis will be enrolled. Inhalation technique will be evaluated by two observers independently at the same time with all three methods (checklist, 4 grade scale, Vitalograph®AIM). To compare these methods, the investigators will analyze method reliability and validity. The reference assessment will be performed by two experienced pulmonologists.\n\nAdditionally, inhalation technique will be evaluated 30 minutes after Vitalograph®AIM based training to analyze the potential benefit of its application in practicing inhalation skills.\n\nOutcomes\n\n1. Comparison of three different methods of assessment of inhalation technique in patients with asthma and COPD (reliability, validity and accuracy)\n2. Difference in the number of mistakes made during inhalation before and after the Vitalograph® AIM based training.\n\nInvestigators expect that results of this study will allow to identify the most accurate method for assessment of inhalation technique. Furthermore, the impact of Vitalograph®AIM based training on inhalation skills will be assessed.."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* informed consent for participating in the study\n* age 18-85 years\n* COPD or asthma diagnosed at least 3 months prior to enrollment\n* using of at least one inhaler regularly every day\n* using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)\n\nExclusion criteria:\n\n* lack of informed consent\n* age \\<18 years or \\> 85 years\n* diagnosis of asthma or COPD not earlier than 3 months before enrollment\n* using inhalers irregularly.\n* symptoms of infection 5 days prior to beginning of the study\n* comorbidity that could prevent patient from using Vitalograph®AIM to teach patient proper inhalation technique (i.e. advanced cognitive disorders, mental diseases, crucial neurological, vision or hearing disorders).'}, 'identificationModule': {'nctId': 'NCT04349735', 'acronym': 'CINTECH', 'briefTitle': 'Comparison of 3 Methods to Assess Inhalation Technique', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Comparison of Three Methods of Assessment of INhalation TECHnique in Patients With Asthma and COPD', 'orgStudyIdInfo': {'id': 'Inhalation technique 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults with asthma or COPD', 'description': 'Assessment of inhalation technique by three methods in all patients', 'interventionNames': ['Other: Assessment of inhalation technique']}], 'interventions': [{'name': 'Assessment of inhalation technique', 'type': 'OTHER', 'description': 'Assessment of inhalation technique by 3 methods in every patient', 'armGroupLabels': ['Adults with asthma or COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Rafał Krenke, MD,PhD,Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marta Dąbrowska', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}