Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT01511302
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2012-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate 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': 'C000627108', 'term': 'RNS60'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'Baseline to 56 days', 'description': 'Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.'}], 'secondaryOutcomes': [{'measure': 'Change in peak expiratory flow', 'timeFrame': 'Baseline to 56 days', 'description': 'Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.'}, {'measure': 'Change in quality of life', 'timeFrame': '56 days', 'description': "Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days."}, {'measure': 'Change in rescue inhaler usage', 'timeFrame': '56 days', 'description': 'Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female non-smokers, aged between 18 and 65 years.\n* Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A.\n* Subjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment.\n* Normal 12-lead ECG at Screening.\n* Normal single view chest x-ray at Screening.\n* Men and women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment (Day 57).\n* Women of childbearing potential who have a negative pregnancy test (serum HCG) at the time of study entry, and again on Day 22.\n* Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary, informed consent.\n\nExclusion Criteria:\n\n* Chronic or acute disease that might interfere with the evaluation of RNS60.\n* Pregnancy, intent to become pregnant, or breastfeeding.\n* Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated).\n* Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody.\n* Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day 22.\n* Infections that require intravenous antibiotic therapy.\n* Significant organ dysfunction, including cardiac, renal, liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry.\n* Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.\n* Treatment with any investigational drugs, therapies, or medical devices within 4 weeks prior to study entry.\n* Any use of antidepressants or other psychiatric medicine within 4 weeks prior to study entry and/or during the study treatment period.\n* Use of any over-the-counter asthma treatments, including Primatene Mist, during the 8-week active study period.'}, 'identificationModule': {'nctId': 'NCT01511302', 'briefTitle': 'Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revalesio Corporation'}, 'officialTitle': 'A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma', 'orgStudyIdInfo': {'id': '01.1.1.H2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RNS60-BD 0.25', 'description': 'RNS60 in combination with Budesonide 0.25mg/2ml concentration', 'interventionNames': ['Drug: RNS60', 'Drug: Budesonide']}, {'type': 'EXPERIMENTAL', 'label': 'RNS60-BD 0.5', 'description': 'RNS60 in combination with Budesonide 0.5mg/2ml concentration', 'interventionNames': ['Drug: RNS60', 'Drug: Budesonide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NS-BD 0.5', 'description': 'Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration', 'interventionNames': ['Drug: Normal Saline', 'Drug: Budesonide']}], 'interventions': [{'name': 'RNS60', 'type': 'DRUG', 'description': 'RNS60, 2ml, nebulized twice daily.', 'armGroupLabels': ['RNS60-BD 0.25', 'RNS60-BD 0.5']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline placebo, 2 ml, nebulized twice daily.', 'armGroupLabels': ['NS-BD 0.5']}, {'name': 'Budesonide', 'type': 'DRUG', 'description': 'Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.', 'armGroupLabels': ['NS-BD 0.5', 'RNS60-BD 0.25', 'RNS60-BD 0.5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Allergy and Asthma', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Research Group', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revalesio Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}