AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide
* Drug: Budesonide
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent prior to the performance of any study-related procedures Age ≥ 18 and ≤ 65 year of age Diagnosis of asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months 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 FEV1 ≥ 40% or ≤ 79% predicted at the Screening or Baseline Visit 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 Mandatory usage of long-acting β-agonists 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!) 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 Exclusion Criteria: History of allergy or adverse experience with Budesonide Pregnant women or nursing mothers Upper respiratory tract infection within 4 weeks of Screening Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening Hospitalization for asthma within 3 months of Screening Use of anti-IgE, methotrexate, oral gold, Dapsone, or i.v. gamma globulin within 3 months of Screening Treatment with other investigational asthma treatment within 30 days prior to Screening Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema History of medication noncompliance History of significant medical illness or condition that in the Investigator's opinion places the subject at undue risk by participating in the study Past episode of anaphylaxis with severe respiratory symptoms Oral corticosteroid average daily dose exceeding a maximum amount Currently smoking or history of smoking ≥ 10 pack years Taking oral or i.v. corticosteroids for any disease indication other than asthma 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide high dose via AKITA (1mg/2ml)<br> | Drug: Budesonide<br> <br> |
| Experimental: Budesonide low dose via AKITA (0.5mg/2ml)<br> | Drug: Budesonide<br> <br> |
| Active Comparator: Budesonide high dose via conventional nebulizer (1mg/2ml)<br> | Drug: Budesonide<br> <br> |
| No Intervention: Placebo via AKITA<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Asthma, requiring chronic oral steroid use