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

Activaero

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: Budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01200108

Acti-AICS-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)