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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| triple combinations | Experimental | Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd |
|
| double combinations | Active Comparator | Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple combinations | Drug | inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the frequency of ACO exacerbation | the frequency of ACO exacerbation | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Shengqing, PhD | Contact | +86-02150887072 | shengqingli@hotmail.com | |
| Zhang Xia, PhD | Contact | +86-02150887073 | xiangruye@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Shengqing, PhD | Huashan Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| double combinations | Drug | inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd) |
|
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |