Moderate and severe adult asthma who controlled with ICS/LABA [GINA step 4 and 5] in KCMH Moderate and severe adult asthma
Conditions
Interventions
Add on Tiotropium handihaler 18 mcg/day,Add on Budesonide MDI 400 mcg/day
Active Comparator Drug,Active Comparator Drug
Tiotropium handihaler,Budesonide MDI
Sponsors
Ratchadapiseksompotch Research Fund
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosis of asthma from clinical presentation and/or confirmed at screening with a bronchodilator reversibility (15–30 minutes after 400 μg salbutamol) resulting in FEV1 or FVC increase of ≥ 12% and ≥ 200 mL or diurnal PEF variability > 10% 2.Diagnosis of asthma lasting 4 weeks or more 3.Patients were required to have been receiving maintenance treatment with stable medium-dose (eg 400 - 800 μg budesonide or equipotent dose) and high-dose ICS (eg > 800 μg budesonide or equipotent dose) and combination with a LABA, for at least 4 weeks prior to screening. 4.Symptomatic asthma was defined as ACT score of </= 19 at screening and prior to randomisation. 5.Never smoked or be ex-smokers who stopped smoking at least 1 year prior to enrolment, with a smoking history of less than 10 pack-years 6.Reliever usage is only salbutamol.
Exclusion criteria
Exclusion criteria: 1.Diagnosis COPD by clinical and spirometry 2.Significant unstable concomitant disease e.g. IHD,CKD stage 5,Advanced stage cancer,Bed ridden,Immunocomprommise host[HIV or patients on immunosupressant] 3.On B-blocker or Biologic therapy within 6 momths prior to randomisation. 4.History of acute exacerbation or respiratory tract infection with in 4 weeks prior to randomisation. 5.Reliever usage is combination salbutamol and ipratropium bromide 6.Pregnancy 7.Patients were not permitted to take any investigational drug or patients denied to enroll in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough forced expiratory volume in 1 second or Trough FEV1 0,4 and 12 weeks after randomization Spirometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma Control Test score or ACT score, Asthma Quality of Life Questionnaire score or AQLQ score 0,4 and 12 weeks after randomization Questionaire,Fractional Exhaled Nitric Oxide or FeNO 0 and 12 weeks after randomization FeNO measure device | — |
Countries
Thailand
Contacts
Public ContactWitchaya Aunanan
Pulmonary and critical care division,King chulalongkorn memorial hospital
Outcome results
None listed