Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05550402
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D056151', 'term': 'Airway Remodeling'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}], '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': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D009241', 'term': 'Ipratropium'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-17', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average FEV1', 'timeFrame': '6 hour', 'description': 'FEV1 determined from serial spirometry and calculated on the basis of area under the curve'}], 'secondaryOutcomes': [{'measure': 'FEV1 at 6 h', 'timeFrame': '6 hour', 'description': 'FEV1 at 6 hours post-dose'}, {'measure': 'Maximum FEV1', 'timeFrame': '6 hour', 'description': 'Maximum FEV1 over the 6-hour serial assessments'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'fixed airway obstruction', 'spirometry', 'parasympathetic activity', 'well controlled'], 'conditions': ['Asthma', 'Airway Obstruction', 'Airway Remodeling', 'Parasympathetic Nervous System Diseases']}, 'descriptionModule': {'briefSummary': 'In asthma, the significant role of pathogenesis is chronic airway inflammation, bronchial hyperresponsiveness, and variable airflow obstruction. Asthma with irreversible or fixed airflow obstruction (FAO) is a clinical phenotype resulting from chronic airway inflammation with having longer disease duration, suggesting that airway remodeling contributes to the decline in lung function seen in individuals with asthma. Although this condition frequently occurs in patients with severe asthma, there are pieces of evidence occurring in those with mild to moderate asthma. According to previous research, low lung function, FEV1 less than 60% predicted, is a robust independent predictor of subsequent asthma attacks and other asthma outcomes, including asthma control and SABA use. In a recent study, the patients with mild to moderate asthma who received mild to medium dosed inhaled corticosteroid plus long-acting beta-2 agonist with or without asthma control showed evidence of FAO with or without bronchodilator reversibility. Therefore parasympathetic activity may be affected by FAO in those patients. The autonomic nervous system plays an essential role in asthma, especially from the parasympathetic, promoting bronchoconstriction and regulating airway inflammation and remodeling. This study hypothesizes that a cholinergic mechanism may play a significant role in FAO across patients with mild, moderate, and severe asthma. This might increase the fundamental evidence leading to early-step treatment with anti-cholinergic medication in early asthma severity driven by FAO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthmatic patients classified by severity Mild (achieved control with using low-dose ICS or as-needed ICS-formoterol) or Moderate (achieved controlled with using low-dose ICS/LABA or Severe ((achieved controlled with using medium to high dose ICS/LABA)\n* Post-bronchodilator (Salbutamol) FEV1/FVC ratio less than 0.75 or below the Lower Limit of Normal (LLN) and Post-bronchodilator (Salbutamol) FEV1 predicted \\< 80% with or without bronchodilator response\n* History of smoking less than 10 pack-years or current smoking\n* Patients who able to do spirometry without contraindication\n* asthma control was defined by ACQ6 \\< 1.5\n\nExclusion Criteria:\n\n* Contraindication for spirometry\n* Chest x-ray suggested any chronic lung diseased\n* Contraindication for anticholinergic drug\n* History of asthma exacerbation within 12 weeks before visit 1\n* History of taking LAMA within 6 months before visit 1'}, 'identificationModule': {'nctId': 'NCT05550402', 'acronym': 'PARASMA', 'briefTitle': 'Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study)', 'organization': {'class': 'OTHER', 'fullName': 'Hat Yai Medical Education Center'}, 'officialTitle': 'Comparison of Parasympathetic Activity in Mild, Moderate, and Severe Asthma With Fixed Airway Obstruction', 'orgStudyIdInfo': {'id': '454554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Salbutamol then ipratropium', 'description': 'Visit 1, After predosed spirometry is done, the patients will be received 4 puffs of salbutamol. 30 minutes later, if they meet the criteria of fixed airway obstruction based on ATS criteria, then they will continue to undergo serial spirometry at 1, 2, 3, and 4 hours. Then, the patients requested to be administered 4 puffs of ipratropium and do spirometry at 4.5 and 5 hours.', 'interventionNames': ['Drug: Salbutamol', 'Drug: Ipratropium Bromide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ipratropium then salbutamol', 'description': 'Visit 2, After predosed spirometry is done, the patients will be received 4 puffs of ipratropium they will continue to undergo serial spirometry at 30 minutes,1, 2, 3, and 4 hours. Then, the patients requested to be administered 4 puffs of salbutamol and do spirometry at 4.5 and 5 hours.', 'interventionNames': ['Drug: Salbutamol', 'Drug: Ipratropium Bromide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salbutamol plus ipratropium', 'description': 'Visit 3, After predosed spirometry is done, the patients will be received 4 puffs of a placebo, and they will do spirometry at 30 minutes, 1 and 2 hours (Placebo arm). Then, the patients requested to be administered 4 puffs of ipratropium and 4 puffs of salbutamol and do spirometry at 4.5 and 5 hours (Salbutamol plus ipratropium)', 'interventionNames': ['Drug: Salbutamol plus Ipratropium Bromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Visit 3, After predosed spirometry is done, the patients will be received 4 puffs of a placebo, and they will do spirometry at 30 minutes, 1 and 2 hours (Placebo arm).', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Salbutamol', 'type': 'DRUG', 'otherNames': ['ventolin'], 'description': 'Visit 1, After predosed spirometry is done, the patients will be received 4 puffs of salbutamol. 30 minutes later, if they meet the criteria of fixed airway obstruction based on ATS criteria, then they will continue to undergo serial spirometry at 1, 2, 3, and 4 hours. Then, the patients requested to be administered 4 puffs of ipratropium and do spirometry at 4.5 and 5 hours.', 'armGroupLabels': ['Ipratropium then salbutamol', 'Salbutamol then ipratropium']}, {'name': 'Ipratropium Bromide', 'type': 'DRUG', 'otherNames': ['Atrovent'], 'description': 'Visit 2, After predosed spirometry is done, the patients will be received 4 puffs of ipratropium they will continue to undergo serial spirometry at 30 minutes,1, 2, 3, and 4 hours. Then, the patients requested to be administered 4 puffs of salbutamol and do spirometry at 4.5 and 5 hours.', 'armGroupLabels': ['Ipratropium then salbutamol', 'Salbutamol then ipratropium']}, {'name': 'Salbutamol plus Ipratropium Bromide', 'type': 'DRUG', 'description': 'Visit 3, After predosed spirometry is done, the patients will be received 4 puffs of a placebo, and they will do spirometry at 30 minutes, 1 and 2 hours (Placebo arm). Then, the patients requested to be administered 4 puffs of ipratropium and 4 puffs of salbutamol and do spirometry at 4.5 and 5 hours (Salbutamol plus ipratropium arm)', 'armGroupLabels': ['Salbutamol plus ipratropium']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Visit 3, After predosed spirometry is done, the patients will be received 4 puffs of a placebo, and they will do spirometry at 30 minutes, 1 and 2 hours (Placebo arm).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Narongwit Nakwan, M.D.', 'role': 'CONTACT', 'email': 'naronak@hotmail.com', 'phone': '074273100', 'phoneExt': '1223'}], 'facility': 'Hatyai Hospital', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'centralContacts': [{'name': 'Narongwit Nakwan, M.D.', 'role': 'CONTACT', 'email': 'naronak@hotmail.com', 'phone': '0818984566'}, {'name': 'Pattarawadee Taptawee, R.N.', 'role': 'CONTACT', 'email': 'taptawee@hotmail.co.th'}], 'overallOfficials': [{'name': 'Narongwit Nakwan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hatyai medical Education Center, Hatyai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hat Yai Medical Education Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Narongwit Nakwan', 'investigatorAffiliation': 'Hat Yai Medical Education Center'}}}}