Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT01200108
Status:
COMPLETED
Last Update Posted:
2011-11-15
First Post:
2010-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With 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': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-14', 'studyFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2011-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Severe Asthma, requiring chronic oral steroid use'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.activaero.de', 'label': 'Homepage of the trial sponsor'}]}, 'descriptionModule': {'briefSummary': 'The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral corticosteroid dose and stability/improvement of clinical parameters related to asthma in the targeted subject population. Ultimately, the goal is to free subjects with severe asthma from the burden of chronic oral steroid therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent prior to the performance of any study-related procedures\n* Age ≥ 18 and ≤ 65 year of age Diagnosis of asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months\n* Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS). Exact baseline level will be measured during the screening period by subject diary entries\n* FEV1 ≥ 40% or ≤ 79% predicted at the Screening or Baseline Visit\n* Documented increase of FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening\n* Mandatory usage of long-acting β-agonists\n* A negative pregnancy test must be available for any women of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!)\n* Women of childbearing potential must agree to use a reliable method of contraception from the screening until 4 weeks after study completion or after study drug discontinuation in case study drug treatment is stopped prematurely. - In this study, hormone-based contraceptives alone are not considered as reliable method\n\nExclusion Criteria:\n\n* History of allergy or adverse experience with Budesonide\n* Pregnant women or nursing mothers\n* Upper respiratory tract infection within 4 weeks of Screening\n* Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening\n* Hospitalization for asthma within 3 months of Screening\n* Use of anti-IgE, methotrexate, oral gold, Dapsone, or i.v. gamma globulin within 3 months of Screening\n* Treatment with other investigational asthma treatment within 30 days prior to Screening\n* Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema\n* History of medication noncompliance\n* History of significant medical illness or condition that in the Investigator's opinion places the subject at undue risk by participating in the study\n* Past episode of anaphylaxis with severe respiratory symptoms\n* Oral corticosteroid average daily dose exceeding a maximum amount\n* Currently smoking or history of smoking ≥ 10 pack years\n* Taking oral or i.v. corticosteroids for any disease indication other than asthma\n* Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide (AST, ALT \\> 3 times upper limit of normal range, serum creatinine \\> 1.5 times upper limit of normal range)"}, 'identificationModule': {'nctId': 'NCT01200108', 'briefTitle': 'AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Activaero GmbH'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Tolerability, Safety and Efficacy of AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma Requiring Chronic Oral Corticosteroid Treatment', 'orgStudyIdInfo': {'id': 'Acti-AICS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide high dose via AKITA (1mg/2ml)', 'interventionNames': ['Drug: Budesonide']}, {'type': 'EXPERIMENTAL', 'label': 'Budesonide low dose via AKITA (0.5mg/2ml)', 'interventionNames': ['Drug: Budesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide high dose via conventional nebulizer (1mg/2ml)', 'interventionNames': ['Drug: Budesonide']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo via AKITA'}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'armGroupLabels': ['Budesonide high dose via AKITA (1mg/2ml)']}, {'name': 'Budesonide', 'type': 'DRUG', 'armGroupLabels': ['Budesonide low dose via AKITA (0.5mg/2ml)']}, {'name': 'Budesonide', 'type': 'DRUG', 'armGroupLabels': ['Budesonide high dose via conventional nebulizer (1mg/2ml)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10717', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53119', 'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '53123', 'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '64287', 'city': 'Darmstadt', 'country': 'Germany', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '60318', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Peter, Kardos, MD', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '35037', 'city': 'Marburg', 'country': 'Germany', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '80331', 'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '63110', 'city': 'Rodgau-Dudenhofen', 'country': 'Germany'}, {'zip': '15562', 'city': 'Rüdersdorf', 'country': 'Germany', 'geoPoint': {'lat': 52.46927, 'lon': 13.78631}}, {'zip': '68723', 'city': 'Schwetzingen', 'country': 'Germany', 'geoPoint': {'lat': 49.38217, 'lon': 8.5823}}, {'zip': '40-752', 'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-159', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '92-215', 'city': 'Lódz', 'country': 'Poland'}, {'zip': '20-954', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-214', 'city': 'Poznán', 'country': 'Poland'}, {'zip': '96-100', 'city': 'Skierniewice', 'country': 'Poland', 'geoPoint': {'lat': 51.95485, 'lon': 20.15837}}, {'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-239', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '49074', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83099', 'city': 'Donetsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61124', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '03680', 'city': 'Kyiv', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}], 'overallOfficials': [{'name': 'Peter Kardos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peter Kardos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Activaero GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Thomas Hofmann', 'oldOrganization': 'Activaero GmbH'}}}}