Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04310618
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mucus Solids Concentration in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-sample variability of sputum concentration (% solids)', 'timeFrame': '2 stable weeks', 'description': '% solids will be calculated by measuring the wet to dry sputum weight ratio'}], 'secondaryOutcomes': [{'measure': 'Inter-sample variability of sputum concentration (% solids)', 'timeFrame': '1 stable day (at 9:00 am, 12:00 am and 17:00 pm)', 'description': '% solids will be calculated by measuring the wet to dry sputum weight ratio'}, {'measure': 'Sputum concentration (% solids) during the first exacerbation after recruitment', 'timeFrame': '1 day', 'description': '% solids will be calculated by measuring the wet to dry sputum weight ratio'}, {'measure': 'Sputum concentration (% solids) one month after the first exacerbation after recruitment', 'timeFrame': '1 day', 'description': '% solids will be calculated by measuring the wet to dry sputum weight ratio'}, {'measure': 'Forced expiratory volume at 1 second', 'timeFrame': 'Baseline', 'description': 'Simple spirometry'}, {'measure': 'Forced vital capacity', 'timeFrame': 'Baseline', 'description': 'Simple spirometry:'}, {'measure': 'Forced expiratory flow 25-75', 'timeFrame': 'Baseline', 'description': 'Simple spirometry'}, {'measure': 'Quality of life related to cough', 'timeFrame': 'Baseline', 'description': 'Leicester Cough Questionnaire (LCQ). Self-administered questionnaire that evaluates the impact of cough in three domains: physical, psychological, and social (each one ranged 1 to 7). It is composed of 19 questions and the "total score (range 3 to 21) is calculated by adding the domain scores together". The lower the score, the greater the severity.'}, {'measure': 'Impact of cough and sputum symptoms of everyday life', 'timeFrame': 'Baseline', 'description': 'Cough and Sputum Assessment Questionnaire (CASA-Q). Self-administered questionnaire that consists of 20 questions organized in four domains (cough symptoms, cough impact, sputum symptoms, and sputum impact). Each domain is ranged from 0 to 100. The total score is expressed over 100 and calculated doing an average of the four domains. The lower the score, the greater the severity.'}, {'measure': 'Breathlessness', 'timeFrame': 'Baseline', 'description': 'Modified Medical Research Council breathlessness scale: self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.'}, {'measure': 'Ease of coughing up', 'timeFrame': 'Baseline', 'description': 'Visual analog scales are 10-cm lines anchored at the ends by words that define the bounds of ease of coughing up options; corresponding 0 to "expectorate is very easy" and 10 to "expectorate is very difficult".'}, {'measure': 'Ease of coughing up', 'timeFrame': 'During the first exacerbation after recruitment', 'description': 'Visual analog scales are 10-cm lines anchored at the ends by words that define the bounds of ease of coughing up options; corresponding 0 to "expectorate is very easy" and 10 to "expectorate is very difficult".'}, {'measure': 'Sputum colour', 'timeFrame': 'Baseline', 'description': 'Sputum colour chart (Murray MP et al.)'}, {'measure': 'Sputum colour', 'timeFrame': 'During the first exacerbation after recruitment', 'description': 'Sputum colour chart (Murray MP et al.)'}, {'measure': 'Exacerbation frequency', 'timeFrame': '12 months before enrollement', 'description': 'Number of exacerbations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mucus concentration'], 'conditions': ['Bronchiectasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/19648517', 'label': 'Sputum colour chart (Murray MP et al.)'}]}, 'descriptionModule': {'briefSummary': 'There is a need for biomarkers that can rapidly and sensitively detect therapeutic benefits of therapies designed to "rehydrate" airways and monitor disease severity and progression. In this study the investigators will evaluate the stability of mucus concentration in patients with bronquiectasis (CF and NCBF) and its ability to respond to acute exacerbations in order to assess whether it can be a good candidate for biomarker.', 'detailedDescription': 'Prospective cross-sectional study of repeated measurements. The recruitment will be performed in 3 different cities of Spain: Zaragoza, Barcelona and Murcia.\n\nSubjects will be asked to repeatedly collect spontaneous and induced sputum samples in both stable and exacerbated conditions. All samples will be collected autonomously by patients in their homes after they have been instructed and supervised. Hypertonic saline nebulization will be used for sputum induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with bronchiectasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of CF (confirmed genetics) or diagnosis of non-CF bronchiectasis through high resolution computed tomography.\n* Aged ≥ 18 years.\n* Clinically stable at the time of recruitment.\n* Chronic sputum production (able to produce spontaneous sputum daily).\n* Current hypertonic saline user.\n* Able to provide written informed consent and perform the trial.\n\nExclusion Criteria:\n\n* Current smoker or \\>10 pack-year history of tobacco use.\n* Patient in transplantation or retransplantation list.'}, 'identificationModule': {'nctId': 'NCT04310618', 'briefTitle': 'Mucus Solids Concentration in Patients With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Jorge'}, 'officialTitle': 'Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study', 'orgStudyIdInfo': {'id': 'wt%_S vs IN'}, 'secondaryIdInfos': [{'id': 'Antonio Dupla Abadal 2018', 'type': 'OTHER_GRANT', 'domain': 'Sociedad Aragonesa de Aparato Respiratorio (SADAR)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with bronchiectasis', 'description': 'Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Adults with bronchiectasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50014', 'city': 'Zaragoza', 'state': 'Aragon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta San Miguel Pagola', 'role': 'CONTACT', 'email': 'msanmiguelpagola@gmail.com'}], 'facility': 'Marta San Miguel Pagola', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Marta San Miguel Pagola, PhD', 'role': 'CONTACT', 'email': 'msanmiguel@usj.es', 'phone': '34617086431'}], 'overallOfficials': [{'name': 'Marta San Miguel Pagola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad San Jorge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Jorge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Asociación Murciana de Fibrosis Quistica', 'class': 'UNKNOWN'}, {'name': 'University of North Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}