Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-15 @ 7:43 AM
Study NCT ID:
NCT03031093
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2016-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerosol Therapy in Obese COPD Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2017-01-21', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern of aerosol lung deposition.', 'timeFrame': 'during the following 25 minutes post inhalation protocol', 'description': 'The pattern of aerosol lung deposition will be compared between obese and non obese participants (with and without COPD) as well as between inhalation with HFNC and without HFNC'}], 'secondaryOutcomes': [{'measure': 'Change of pulmonary function after bronchodilators administration. (with and without HFNC)', 'timeFrame': 'Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.', 'description': 'pulmonary function will be evaluated previously to the inhalation protocol. After the inhalation protocol, this measurement will be assessed again in order to check the effect of bronchodilator drug.'}, {'measure': 'Upper airways anatomical variables CT scans', 'timeFrame': 'first day of study', 'description': 'Upper airways anatomical variables will be measured by CT scans.'}, {'measure': 'Mallampati Score', 'timeFrame': 'first day of study', 'description': 'Mallampati Score (from 1 to 4)'}, {'measure': 'BMI', 'timeFrame': 'first day of study', 'description': 'Body mass index'}, {'measure': 'Muscle Mass', 'timeFrame': 'first day of study', 'description': 'Muscle Mass percentage'}, {'measure': 'Body fat', 'timeFrame': 'first day of study', 'description': 'Body fat percentage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aerosol therapy', 'pulmonary scintigraphy', 'upper airways anatomy', 'High Flow Nasal Cannula'], 'conditions': ['Chronic Obstructive Pulmonary Disease Moderate', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '32917355', 'type': 'DERIVED', 'citation': 'Rocha T, Rattes C, Morais C, Souza R, Rolim N, Brandao S, Fink JB, Dornelas de Andrade A. Predictive anatomical factors of lung aerosol deposition in obese individuals. Would modified mallampati score be relevant? Clinical trial. Respir Med. 2020 Sep;171:106083. doi: 10.1016/j.rmed.2020.106083. Epub 2020 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.', 'detailedDescription': 'This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and then formulate specific strategies to control the evolution of this disease. The suggested strategy in order to implement the aerosol therapy is the use of High Flow Nasal Cannula (HFNC) during these patient´s inhalation therapy.\n\nIt will consist in a cross-over clinical trial. The population will be composed by volunteers of both genders, aged between 45-70 years old. Four distinct groups will be formed: obese participants without copd; obese participants with copd; non obese participants without copd; non-obese participants with copd.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHEALTHY, non obese\n\n* no history of respiratory disease\n* non smokers\n* self declared sedentary\n* Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted\n* Forced Vital capacity (FVC) equal or higher than 80% of predicted;\n* FEV1/FVC higher than 70% of predicted.\n* BMI lower than 30 kg/m2\n\nHEALTHY, obese\n\n* no history of respiratory disease\n* non smokers\n* self declared sedentary\n* Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted\n* Forced Vital capacity (FVC) equal or higher than 80% of predicted\n* FEV1/FVC higher than 70% of predicted.\n* BMI equal or higher than 30 kg/m2\n\nCOPD participants, non obese\n\n* ex smokers\n* clinical stability (six previous weeks)\n* FEV1 lower than 80% of predicted.\n* FEV1/FVC lower than 70 % post bronchodilator.\n* No cardiopulmonary diseases (self declared)\n* BMI lower than 30 kg/m2\n\nCOPD participants, obese\n\n* ex smokers\n* clinical stability (six previous weeks)\n* FEV1 lower than 80% of predicted.\n* FEV1/FVC lower than 70 % post bronchodilator.\n* No cardiopulmonary diseases (self declared)\n* BMI equal or higher than 30 kg/m2\n\nExclusion Criteria:\n\n* Difficulty to understand verbal commands\n* exacerbations during the study period'}, 'identificationModule': {'nctId': 'NCT03031093', 'briefTitle': 'Aerosol Therapy in Obese COPD Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Aerosol Therapy With High Flow Nasal Cannula (HFNC) in Obese COPD Patients. Aerosol Deposition Pattern and Predictive Values.', 'orgStudyIdInfo': {'id': 'CAAE: 57946516.0.0000.5537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy, non obese + HFNC', 'description': 'Healthy, non obese participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol', 'Device: High Flow Nasal Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy, non obese', 'description': 'Healthy, non obese participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'COPD, non obese + HFNC', 'description': 'non obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol', 'Device: High Flow Nasal Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'COPD, non obese', 'description': 'non obese COPD participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'healthy, obese + HFNC', 'description': 'Healthy obese participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol', 'Device: High Flow Nasal Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy, obese', 'description': 'Healthy obese participants will perform the following inhalation protocol: aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'COPD, obese + HFNC', 'description': 'Obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol', 'Device: High Flow Nasal Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'COPD, obese', 'description': 'Obese COPD participants will perform the following inhalation protocol:aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min).', 'interventionNames': ['Radiation: inhalation protocol']}], 'interventions': [{'name': 'inhalation protocol', 'type': 'RADIATION', 'description': 'technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution', 'armGroupLabels': ['COPD, non obese', 'COPD, non obese + HFNC', 'COPD, obese', 'COPD, obese + HFNC', 'Healthy, non obese', 'Healthy, non obese + HFNC', 'healthy, obese', 'healthy, obese + HFNC']}, {'name': 'High Flow Nasal Cannula', 'type': 'DEVICE', 'description': 'aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula will deliver the aerosol at a 30L/min flow of oxigen.', 'armGroupLabels': ['COPD, non obese + HFNC', 'COPD, obese + HFNC', 'Healthy, non obese + HFNC', 'healthy, obese + HFNC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50670-901', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Universidade Federal de Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'overallOfficials': [{'name': 'Armele Dornelas de Andrade, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de Pernambuco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master in Physiotherapy', 'investigatorFullName': 'Taciano Dias de Souza Rocha', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}