Asthma MedDRA version: 22.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Budesonid
Product Name: budesonid
Product Code: budesonid
Pharmaceutical Form:
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Current Sponsor code: budesonid
Trade Name: fluticas
Sponsors
Respiratory Research Unit Hvidovre, Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Asthma patients followed in the Respiratory Outpatient Ward, Amager Hvidovre Hospital, Glostrup Hospital, Herlev-Gentofte Hospital, Bispebjerg Hospital. - At least one of the following test suggestive for asthma, performed at any time during the outpatient course: o 1) FEV1-reversibility of at least 12% and 200 ml after administration of bronkodilator or Prednisolon course. o 2) positiv bronkialprovokation test, such as mannitol, or o 3) peakflow (PF)- variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms. o 4) Variability in FEV1 over time on at least 12% and 200 ml - Age 18-65 years - Treated with ICS daily in doses equivalent to Budesonid 800 microgram daily or more - ICS adherence of at least 80% during the last year, assessed from used prescriptions - FeNO =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of allergic asthma - Doctor-diagnosed pneumonia within 6 weeks prior to screening - Daily smoking or former daily smoking within the last 6 months - Known other respiratory condition such as COPD or pulmonary sarcoidosis - Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor - Pregnancy or planned pregnancy - Abuse of alcohol or other recreational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is to investigate whether asthma patients expressing low T2-activity, assessed by Serum-Periostin, blood-eosinophils, and FeNO can sustain their level of disease control during tapering of ICS. The overall aim of the study is to reduce the burden of corticosteroids in these patients. ;Secondary Objective: Not applicable;Primary end point(s): Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS and/or time from baseline to drop-out because of worsening of asthma symptoms. Clinically significant change will be 0.5 points. ;Timepoint(s) of evaluation of this end point: 1. Week 0, 4, 8, 12, 16, 26, 52. 2. Single measurement at drop-out | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in FeNO 2. Change in Serum-Periostin. 3. Change in FEV1. 4. Change in Blood-eosinophils 5. Change in Sputum-eosinophils;Timepoint(s) of evaluation of this end point: 1. Week 0, 4, 8, 12, 16, 26, 52. 2. Week 0, 8, 16, 52. 3. Week 0, 4, 8, 12, 16, 26, 52. 4. Week 0, 4, 8, 12, 16, 26, 52. 5. Week 0, 52. | — |
Countries
Denmark
Contacts
Public ContactRespiratory Research Unit Hvidovre
Respiratory Research Unit Hvidovre, Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre
Outcome results
None listed