Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00421018
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2007-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2007-01-10', 'studyFirstSubmitQcDate': '2007-01-10', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-AQLQ (Asthma-Related Quality of Life)', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Asthma', 'Allergy', 'Cytokines', 'Glucocorticoids', 'Inflammation', 'Nitric Oxide (NO)', 'Quality of Life', 'Self-Rated Health', 'Stress'], 'conditions': ['Allergic Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-64\n* Clinical diagnosis of Asthma\n* Glucocorticoid treatment \\> 6 months.\n* Verified Allergy\n* Read and speak Swedish\n\nExclusion Criteria:\n\n* Smoking\n* Current regular treatment with long-acting beta2-agonist\n* Treatment with Singulair only or in combination with glucocorticoids\n* Taking part in other research study\n* Pregnancy or breast-feeding\n* Unstable Asthma'}, 'identificationModule': {'nctId': 'NCT00421018', 'briefTitle': 'Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK)', 'orgStudyIdInfo': {'id': '20050166'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Symptom-guided group', 'description': 'Anti-inflammatory treatment is guided conventionally according to symptoms and beta-2-agonist use.', 'interventionNames': ['Drug: Single corticosteroid inhalers and Singulair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FeNO-guided group', 'description': 'Anti-inflammatory treatment is guided according to the level of exhaled nitric oxide', 'interventionNames': ['Drug: Single corticosteroid inhalers and Singulair']}], 'interventions': [{'name': 'Single corticosteroid inhalers and Singulair', 'type': 'DRUG', 'description': 'Treatment steps according to preset algorithm', 'armGroupLabels': ['FeNO-guided group', 'Symptom-guided group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Upplands Vasby', 'country': 'Sweden', 'facility': 'Runby Primary Health Care Center', 'geoPoint': {'lat': 59.51839, 'lon': 17.91128}}], 'overallOfficials': [{'name': 'Kjell Alving, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Aerocrine AB', 'class': 'INDUSTRY'}, {'name': 'Phadia AB', 'class': 'UNKNOWN'}, {'name': 'Meda AB', 'class': 'UNKNOWN'}, {'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}, {'name': 'Swedish Council for Working Life and Social Research', 'class': 'OTHER'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Kjell Alving/ Professor', 'oldOrganization': 'Uppsala University'}}}}