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

Not Applicable

• Conditions: Asthma-COPD Overlap
• Interventions: Drug: triple combinations; Drug: double combinations

• Registration Number: NCT03504527
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-28
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-12
• Last Update Submitted: 2018-04-12
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20
• Study Start: 2018-05-01
• Primary Completion: 2018-11-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
triple combinations	triple combinations	Budesonide/Fermotil inhalant 160ug/4.5ug bid; Tiotropium bromide inhalants 18ug qd
double combinations	double combinations	Fermotil inhalants 4.5ug bid; Tiotropium bromide inhalants 18ug qd

Primary Outcome Measures

Name	Time	Method
the frequency of ACO exacerbation	12 months	the frequency of ACO exacerbation

Secondary Outcome Measures

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