Compared add-on Tiotropium handihaler and increasing dose of ICS in moderate and severe adult asthma who controlled with ICS/LABA

Phase 3

Recruiting

• Conditions: Moderate and severe adult asthma who controlled with ICS/LABA[GINA step 4 and 5] in KCMH; Moderate and severe adult asthma

• Registration Number: TCTR20201111002
• Lead Sponsor: Ratchadapiseksompotch Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-11
• Study Completion: 2021-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Diagnosis of asthma from clinical presentation and/or confirmed at screening with a bronchodilator reversibility (15â€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 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trough forced expiratory volume in 1 second or Trough FEV1 0,4 and 12 weeks after randomization Spirometry

Secondary Outcome Measures

Name	Time	Method
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