Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-04 @ 6:37 PM
Study NCT ID:
NCT01562093
Status:
TERMINATED
Last Update Posted:
2016-08-31
First Post:
2012-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D015508', 'term': 'Nasal Obstruction'}], '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': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Investigational drugs no longer available', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2012-03-21', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'forced expiratory volume', 'timeFrame': 'up to 12 weeks', 'description': 'spirometry, methacholine and mannitol'}], 'secondaryOutcomes': [{'measure': 'improvement in nasal blockage', 'timeFrame': 'up to 12 weeks', 'description': 'Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)'}, {'measure': 'nasal and exhaled NO', 'timeFrame': 'up to 12 weeks', 'description': 'NO level in the nasal and exhaled air is measured by the chemiluminescence method with a LR 2000 nitric oxide gas analyser (Logan Research, Rochester, UK)'}, {'measure': 'wheeze', 'timeFrame': 'up to 12 weeks', 'description': 'Pulmotrack wheeze meter'}, {'measure': 'subjective improvement in asthma symptomatology', 'timeFrame': 'up to 12 weeks', 'description': 'Asthma Control Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adrenal Cortex Hormones', 'Spirometry', 'Administration, Intranasal', 'Nasal blockage', 'Nasal sprays'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.', 'detailedDescription': 'Although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. This is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication.\n\nThe "Unified Airways" concept considers the upper and lower airways as one unified airway. In recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms.\n\nConditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. Together will these mechanisms lead to a worsening of the asthmatic disease.\n\nThe aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. The primary outcome variable is improvement in asthma symptomatology. The secondary outcome variables are improvement in nasal blockage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asthma (according to British Thoracic Society guideline)\n* \\>18 years\n\nExclusion Criteria:\n\n* pregnancy\n* systemic disease with nasal manifestations\n* cancer of the nose\n* currently receiving cancer therapy\n* previous nose surgery'}, 'identificationModule': {'nctId': 'NCT01562093', 'briefTitle': 'Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2009/158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'local nasal steroids', 'interventionNames': ['Drug: corticosteroid nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo nasal spray']}], 'interventions': [{'name': 'corticosteroid nasal spray', 'type': 'DRUG', 'otherNames': ['Avamys'], 'description': 'fluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in each nostril for 3 months', 'armGroupLabels': ['local nasal steroids']}, {'name': 'placebo nasal spray', 'type': 'DRUG', 'description': 'formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olav University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Sverre Steinsvåg, MD prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olav University Hospital, Trondheim, Norway'}, {'name': 'Malcolm Sue-Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Olavs University Hospital Trondheim'}, {'name': 'Vegard Bugten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Olavs University Hospital Trondheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}