Subjects with Asthma Requiring Chronic Oral Corticosteroid Treatment MedDRA version: 12.0 Level: LLT Classification code 10003555 Term: Asthma bronchial
Conditions
Interventions
Trade Name: BudenoBronch
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
Activaero GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of the study are to evaluate efficacy, safety and airway tolerability of nebulized Budesonide in subjects with asthma requiring chronic oral corticosteroid treatment. Primary efficacy endpoint To monitor the efficacy of nebulized Budesonide using the AKITA JET nebulizer (test treatment) compared to placebo in subjects with asthma requiring chronic oral corticosteroid treatment by the total number of subjects who are able reduce their oral daily corticosteroid dose by = 50% from baseline (Day 0) and remain clinically stable for = 4 weeks from the final taper (Week 14) to the end of treatment period (Week 18) ((median of the last 4-week treatment period = 0.5 * median of the 4-week screening period)) ;Secondary Objective: Secondary efficacy endpoints are to monitor the efficacy of nebulized Budesonide in subjects with asthma : Mean reduction of OCS (mg) from baseline to week 18 Portion of patients completely weaned off OCS by week 18 Number and percent of subjects with asthma instability Time to asthma instability Change and percent change in FEV1(L) from Baseline Change in FEV1% predicted from Baseline Changes in peak flow rates and asthma symptom scores Change in average number of puffs of Salbutamol per day from Baseline Change and percent change in number of nocturnal awakenings from Baseline Change and percent change in Asthma Quality of Life Scores Number of days of hospitalization Absenteeism from work/school ;Primary end point(s): The primary endpoint is the number of subjects able to reduce their OCS dose by = 50% of Baseline and remain clinically stable for = 4 weeks from the final taper (Week 14) to the End of Treatment Visit (Week 18). | — |
Countries
Germany, Poland
Outcome results
None listed