Clinical trial NCT03504527: Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma-COPD Overlap
Keywords: ICS
LABA
LAMA
therapy
asthma
COPD
ACO
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)
* 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

Primary outcomes:
measure: the frequency of ACO exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: postbronchodilator FEV1
timeFrame: 12 months
measure: times of hospital readmission caused by exacerbation
timeFrame: 12 months
measure: other lung function parameters
timeFrame: 12 months
measure: CCQ score
timeFrame: 12 months
measure: mMRC score
timeFrame: 12 months
measure: CAT score
timeFrame: 12 months
measure: ACT score
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Li Shengqing, PhD
role: PRINCIPAL_INVESTIGATOR
References: