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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Activaero GmbH
• Treatments: Budesonide

Criteria

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)