Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 11:04 AM
Study NCT ID:
NCT06110403
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in ventilation pattern complexity and variability', 'timeFrame': 'between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)', 'description': '* Noise limit: %\n* Lyapounov component: bits/iteration no combination possible'}], 'secondaryOutcomes': [{'measure': 'Change impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz', 'timeFrame': 'between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose', 'description': 'resistance and reactance: kPa/L/s'}, {'measure': 'Changes in FEV1 (spirometry)', 'timeFrame': 'between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose'}, {'measure': 'Change Plethysmographic Functional residual capacity (FRC)', 'timeFrame': 'between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose'}, {'measure': 'Changes measurement for noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1and FRC versus TDI at V3', 'timeFrame': 'between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min)', 'description': 'TDI at V3 (in term of continuous variable and in term of binary variable "responder/non responder"; a response is defined by a change in TDI ≥ +1 between baseline and V3)'}, {'measure': 'Baseline dyspnea index ( BDI)', 'timeFrame': 'before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)'}, {'measure': 'Transition dyspnea index (TDI)', 'timeFrame': 'before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)'}, {'measure': 'Modified dyspnea profile ( MDP)', 'timeFrame': 'before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)'}, {'measure': 'CAT score : COPD assessment test,', 'timeFrame': 'before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes at one month)', 'description': 'range 0 to 40, 40 meaning the worst condition'}, {'measure': 'Likert scale for dyspnea and general health', 'timeFrame': 'before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)', 'description': 'Likert scale change in dyspnea : - 3 to + 3, + 3 maximal improvement, -3 maximal deterioration Likert scale change in general health : - 3 to + 3, + 3 maximal improvement, -3 maximal deterioration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'bronchodilator', 'ventilatory mode', 'variability', 'forced oscillations', 'spirometry', 'plethysmography', 'dyspnea'], 'conditions': ['Copd']}, 'descriptionModule': {'briefSummary': 'Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed informed consent prior to any study specific procedure\n* Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)\n* Documented history of COPD with a post-bronchodilator FEV1/FVC \\<0.70 and a post-bronchodilator 30 % \\< FEV1 \\<70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening\n* Smoking history \\> 10 pack-years\n* Baseline significant dyspnea with a mMRC ≥ 2\n\nExclusion Criteria:\n\n* History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)\n* Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening\n* Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters:\n\n * Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months.\n * Congestive heart failure New York Heart Association (NYHA) class III/IV.\n * Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease).\n * Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia.\n * Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker.\n * Sinus node dysfunction with pauses.\n * Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome.\n * QTcF interval \\>470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/\\[RR1/3\\]).\n * Any other ECG abnormality deemed clinically significant by the Investigator.\n * Bradycardia with ventricular rate \\< 45 bpm.\n * Uncontrolled hypertension (\\> 165/95 mmHg).\n* Clinically relevant respiratory conditions (other than COPD)\n* Severe renal impairment eGFR \\< 30\n* Hepatic impairment\n* Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.\n* Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant\n* Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min)\n* Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids\n* Pregnancy or breastfeeding\n* Woman of childbearing age without effective contraception\n* Any type of cancer within 5 years\n* Patients under guardianship\n* Refuse or incapacity to give an informed consent\n* Absence of social insurance"}, 'identificationModule': {'nctId': 'NCT06110403', 'acronym': 'VARI-OSCIL', 'briefTitle': 'Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient', 'orgStudyIdInfo': {'id': '2022_0422'}, 'secondaryIdInfos': [{'id': '2022-003784-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Symptomatic COPD patients in stable condition treated with BGF 160 (Trixéo Aerosphere®), a combination of budesonide, formoterol and glycopyrronium in a metered dose inhaler, taken twice a day', 'interventionNames': ['Drug: TRIXEO AEROSPHERE']}], 'interventions': [{'name': 'TRIXEO AEROSPHERE', 'type': 'DRUG', 'description': 'BGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) as an inhalation aerosol. Oral inhalation: 2 inhalations of BGF 160 twice daily for 30 days.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry PEREZ, md', 'role': 'CONTACT'}, {'name': 'Thierry PEREZ, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Thierry PEREZ, MD', 'role': 'CONTACT', 'email': 'thierry.perez@chu-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thierry PEREZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}