Clinical trial NCT01200108 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: budesonide, budesonide, budesonide
SMILES: COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1
Eligibility 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)