Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-30 @ 4:55 AM
Study NCT ID:
NCT00829257
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2009-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2009-01-26', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alveolar nitric oxide', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '22568828', 'type': 'RESULT', 'citation': 'Williamson PA, Short PM, Vaidyanathan S, Lipworth BJ. Inhaled and systemic corticosteroid response in severe asthma assessed by alveolar nitric oxide: a randomized crossover pilot study of add-on therapy. Br J Clin Pharmacol. 2013 Jan;75(1):93-102. doi: 10.1111/j.1365-2125.2012.04319.x.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Refractory, non-smoking asthmatics with FEV1 les than 80% predicted\n* RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.\n* Informed consent and ability to perform exhaled nitric oxide assessment.\n* Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.\n\nExclusion Criteria:\n\n* Recent respiratory infection or oral steroid use.\n* Pregnancy or lactation.\n* Known or suspected contra-indication to any of the IMP's.\n* CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit."}, 'identificationModule': {'nctId': 'NCT00829257', 'acronym': 'PAW01', 'briefTitle': 'Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma', 'orgStudyIdInfo': {'id': 'PAW01'}, 'secondaryIdInfos': [{'id': 'Eudract no: 2008-001811-40', 'type': 'REGISTRY', 'domain': '2008RC10'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fine particle steroid inhaler', 'description': 'HFA-BDP plus Fluticasone/Salmeterol Combination', 'interventionNames': ['Drug: HFA-BDP', 'Drug: Seretide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coarse Particle Inhaler', 'description': 'FP plus Fluticasone/Salmeterol combination', 'interventionNames': ['Drug: Fluticasone', 'Drug: Seretide']}], 'interventions': [{'name': 'HFA-BDP', 'type': 'DRUG', 'description': 'HFA-BDP (Qvar) 100ug 2puff b.i.d', 'armGroupLabels': ['Fine particle steroid inhaler']}, {'name': 'Fluticasone', 'type': 'DRUG', 'description': 'Fluticasone propionate Accuhaler 250ug b.i.d.', 'armGroupLabels': ['Coarse Particle Inhaler']}, {'name': 'Seretide', 'type': 'DRUG', 'description': 'Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d', 'armGroupLabels': ['Coarse Particle Inhaler', 'Fine particle steroid inhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Asthma and Allergy Research Group, Ninewells Hospital and Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Peter A Williamson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Brian J Lipworth', 'investigatorAffiliation': 'University of Dundee'}}}}