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

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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma-COPD Overlap
• Intervention / Treatment: Drug: triple combinations; Drug: double combinations

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Principal Investigator: Li Shengqing, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: COPD; asthma; ICS; therapy; LABA; ACO; LAMA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide; Tiotropium Bromide; Bromides
• Other Study ID Numbers: KY2017-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No