Status:
COMPLETED
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
Lead Sponsor:
Activaero GmbH
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
End Date :
November 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01200108
Start Date
March 1 2010
End Date
November 1 2011
Last Update
November 15 2011
Active Locations (24)
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1
Berlin, Germany, 10717
2
Bonn, Germany, 53119
3
Bonn, Germany, 53123
4
Darmstadt, Germany, 64287