Asthma-COPD Overlap
Conditions
Keywords
ICS, LABA, LAMA, therapy, asthma, COPD, ACO
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.
Interventions
DRUGtriple combinations
inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
DRUGdouble combinations
inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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) * allergic to the budesonide, formoterol or tiotropium bromide; * history of acute gastrointestinal bleeding within 3 months; * with severe angle closure glaucoma patients; * pregnancy,lactation; * have participated in other clinical trials in 3 months； * hospital staff and their relatives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the frequency of ACO exacerbation | 12 months | the frequency of ACO exacerbation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| times of hospital readmission caused by exacerbation | 12 months | times of hospital readmission caused by exacerbation |
| other lung function parameters | 12 months | other lung function parameters(%FEV1, FEV1/FVC) |
| CCQ score | 12 months | Clinical COPD Questionnaire score |
| postbronchodilator FEV1 | 12 months | a post-bronchodilator forced expiratory volume in one second |
| CAT score | 12 months | COPD Assessment Test score |
| ACT score | 12 months | Asthma Control Test score |
| mMRC score | 12 months | modified Medical Research Council score |
Contacts
Primary ContactLi Shengqing, PhD
Backup ContactZhang Xia, PhD
Outcome results
None listed