Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-05 @ 5:42 PM
Study NCT ID:
NCT01374932
Status:
UNKNOWN
Last Update Posted:
2012-06-22
First Post:
2011-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-01-10', 'releaseDate': '2016-11-14'}], 'estimatedResultsFirstSubmitDate': '2016-11-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D020181', 'term': 'Sleep Apnea, 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': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2011-05-30', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma control questionnaire', 'timeFrame': '6 months', 'description': 'Changes in clinical and functional variables and in the asthma control questionnaire (ACQ) in the period prior to start the CPAP treatment and after a 6-months follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Obstructive Sleep Apnea Syndrome'], 'conditions': ['Asthma', 'Obstructive Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a before/after Continuous Positive Airway Pressure (CPAP) assessment in participating patients. It aims to answer the following question: Is there an improvement in asthma in those patients with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with CPAP after six months?. It is hypothesized that treatment of OSAS with CPAP in patients with both OSAS and asthma concommitantly, may have a beneficial effect also on asthma outcomes. This clinical effect in asthma could be assessed objectively by applying validated questionnaires for quality of life and asthma control.', 'detailedDescription': 'Full protocol in Spanish, available upon request'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 to 70 yrs.) with asthma who require treatment with CPAP because of OSAS (RDI\\> = 20 events per hour)\n\nExclusion Criteria:\n\n* unstable or severe comorbidity,\n* patients in treatment with drugs that interfere with the clinical course of asthma and/or OSAS,\n* cognitive/psychiatric disorders that preclude patient participation/cooperation,\n* COPD or other lung disease accompanied by chronic airflow limitation, and\n* any clinical condition considered severe enough by the investigators to preclude all the diagnostic and therapeutic procedures outlined in this protocol.'}, 'identificationModule': {'nctId': 'NCT01374932', 'acronym': 'CPASMA', 'briefTitle': 'CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?', 'organization': {'class': 'NETWORK', 'fullName': 'Cimera'}, 'officialTitle': 'The CPASMA Trial: Is There an Improvement in Asthma in Patients With Both Asthma and Obstructive Sleep Apnoea Syndrome (OSAS) Treated With Continuous Positive Airway Pressure (CPAP) After Six Months?', 'orgStudyIdInfo': {'id': 'The CPASMA trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP (see below)', 'description': 'Adult patients with asthma who require treatment with CPAP because of OSAS (RDI\\> = 20 events per hour). CPAP will be administered according to SEPAR guidelines and tailored to individual characteristics', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'otherNames': ['Brand names will be added during fieldwork'], 'description': 'Continuous positive airways pressure (CPAP)', 'armGroupLabels': ['CPAP (see below)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Inca', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Serrano, MD', 'role': 'CONTACT', 'email': 'jserrano@separ.es'}, {'name': 'José Serrano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital comarcal de Inca', 'geoPoint': {'lat': 39.7211, 'lon': 2.91093}}, {'city': 'Alcalá de Henares', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Soledad Alonso Viteri, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Príncipe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vicente Plaza Moral, MD', 'role': 'CONTACT', 'email': 'vplaza@santpau.cat'}], 'facility': 'Hospital de la Santa Creu i de Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Merce Mayos Perez, MD', 'role': 'CONTACT'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cadiz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Gregorio Soto Campos, MD', 'role': 'CONTACT'}], 'facility': 'Hospital de Jerez', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Cantabria.', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Luis García Rivero, MD', 'role': 'CONTACT'}], 'facility': 'Hospital de Laredo'}, {'city': 'Las Palmas', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carlos Cabrera López, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Dr. Negrín', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sagrario Mayoralas Alises, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Moncloa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antolin Lopez Viña, MD', 'role': 'CONTACT', 'email': 'alopezv@separ.es'}], 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Sabadell', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Isabel Sogo Sagardia, MD', 'role': 'CONTACT'}, {'name': 'Laura Vigil Giménez., MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Corporació Sanitària Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'José Serrano, MD', 'role': 'CONTACT', 'email': 'jserrano@separ.es', 'phone': '+34-971888500', 'phoneExt': '4020'}, {'name': 'Joan B Soriano, MD', 'role': 'CONTACT', 'email': 'jbsoriano@caubet-cimera.es'}], 'overallOfficials': [{'name': 'Jose Serrano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Inca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cimera', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Programme Director', 'investigatorFullName': 'Dr. Joan B Soriano', 'investigatorAffiliation': 'Cimera'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-11-14', 'type': 'RELEASE'}, {'date': '2017-01-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Joan B Soriano, Programme Director, Cimera'}}}}