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 Treatmentt

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 195

Inclusion Criteria

1.Written informed consent prior to the performance of any study-related procedures
2.Age = 18 and = 65 year of age
3.Diagnosis of asthma (ATS definition, either allergic or non-allergic) for = 6 months
4.Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS) with a minimum of at least 5 mg/day oral corticosteroids, up to a maximum of 40 mg/day or 80mg/day if taken every other day. Exact baseline level of OCS and SABA will be measured during the screening period by subject diary entries.
5.FEV1 = 40% or = 79% predicted at the Screening or Baseline Visit
6.Documented increase of at least 12% in absolute FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening.
7.?Mandatory usage of long-acting ß-agonists
8.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!)
9.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
(Effective hormonal methods of birth control with a pearl index <1 include prescription combined hormonal contraceptives, hormonal contraceptive injections, and hormonal intrauterine devices. Additionally accepted are male partner vasectomized or female subjects with a hysterectomy or bilateral tubal ligation.)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.History of allergy or adverse experience with Budesonide
2.Pregnant women or nursing mothers
3.Upper respiratory tract infection within 4 weeks of Screening
4.Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
5.Hospitalization for asthma within 3 months of Screening
6.Use of anti-IgE, methotrexate, oral gold, Dapsone, or IV gamma globulin within 3 months of Screening.
7.Treatment with other investigational asthma treatment within 30 days prior to Screening.
8.Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema
9.History of medication noncompliance
10.History of significant medical illness or condition that in the Investigator’s opinion places the subject at undue risk by participating in the study
11.Past episode of anaphylaxis with severe respiratory symptoms
12.Oral corticosteroid average daily dose of > 40mg/day or > 80mg/day if taken every other day
13.Currently smoking or history of smoking = 10 pack years
14.Taking oral or i.v. corticosteriods for any disease indication other than asthma
15.Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide:
•LFTs (AST, ALT) > 3 times upper limit of normal range
•Serum creatinine > 1.5 times upper limit of normal range

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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