Effeciency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of Asthma-chronic Obstructive Pulmonary Overlap: A Randomized Controlled Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- triple combinations
- Conditions
- Asthma-COPD Overlap
- Sponsor
- Huashan Hospital
- Enrollment
- 120
- Primary Endpoint
- the frequency of ACO exacerbation
- Last Updated
- 8 years ago
Overview
Brief Summary
This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.
Detailed Description
ACO(asthma-chronic obstructive pulmonary overlap) is a relatively new proposed clinical form of chronic airway disease. Guideline or preferring therapy for ACO is still evolving. Current clinical solution is when ACO presents like asthma, initial treatment will accord to the guideline for asthma , while it presents like COPD, COPD recommendation treatment (not alone ICS,but ICS in addition of LABA with or without LAMA) will be chosen, which are subjective. Although present guidelines has recommended that ACO should be treated with at last two inhalant, but limited date have proven it. A random controlled trial will be conducted to evaluate the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium bromide) in the treatment of acute exacerbation of ACO,compared with the control group receiving tiotropium bromide with formoterol only.
Investigators
Shengqing Li
Chief physician, professor
Huashan Hospital
Eligibility Criteria
Inclusion Criteria
- •subject has ACO
Exclusion Criteria
- •acute exacerbation of ACO;
- •acute infection;
- •postbrochodilator FEV1/FVC\> 0.7;
- •pulmonary complications: bronchiectasis, active tuberculosis, pulmonary fungal disease or lung cancer
- •history of other malignant tumor
- •with rheumatic diseases;
- •with some serious heart, cerebrovascular, liver, kidney or hematopoietic system diseases
- •with tachyarrhythmias；
- •mental patients;
- •with moderate to severe renal insufficiency (creatinine clearance ≤ 50ml / h)
Arms & Interventions
triple combinations
Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd
Intervention: triple combinations
double combinations
Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd
Intervention: double combinations
Outcomes
Primary Outcomes
the frequency of ACO exacerbation
Time Frame: 12 months
the frequency of ACO exacerbation
Secondary Outcomes
- postbronchodilator FEV1(12 months)
- mMRC score(12 months)
- times of hospital readmission caused by exacerbation(12 months)
- CAT score(12 months)
- ACT score(12 months)
- other lung function parameters(12 months)
- CCQ score(12 months)