Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Asthma-COPD Overlap

Intervention / Treatment
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* Drug: triple combinations
* Drug: double combinations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: triple combinations<br>Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd | Drug: triple combinations<br>* inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)<br>* Other names: budesonide/formotero/tiotropium bromide triple combinations;|
| Active Comparator: double combinations<br>Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd | Drug: double combinations<br>* inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)<br>* Other names: formotero/tiotropium bromide double combinations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of ACO exacerbation | the frequency of ACO exacerbation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postbronchodilator FEV1 | a post-bronchodilator forced expiratory volume in one second | 12 months | 
| times of hospital readmission caused by exacerbation | times of hospital readmission caused by exacerbation | 12 months | 
| other lung function parameters | other lung function parameters(%FEV1, FEV1/FVC) | 12 months | 
| CCQ score | Clinical COPD Questionnaire score | 12 months | 
| mMRC score | modified Medical Research Council score | 12 months | 
| CAT score | COPD Assessment Test score | 12 months | 
| ACT score | Asthma Control Test score | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICS, LABA, LAMA, therapy, asthma, COPD, ACO