Clinical trial NCT03563001: Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
Official title: Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
Small Airway Disease
Quality of Life
Keywords: chronic obstructive pulmonary disease
asthma-chronic obstructive pulmonary disease overlap
small airway
quality of life
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with diagnosis of simple chronic obstructive pulmonary disease(COPD) and asthma-chronic obstructive pulmonary disease overlap(ACO) are recruited.Small airways function of subjects in both group(chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap) is assessed at baseline.And then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.The subjects will have a follow-up visit with the same examinations after 3 months' treatment.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).The assessment of quality of life is also carried out through questionnaires.

Detailed description: This is a randomized,open-label study to research the differences of small airways function between simple chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).Assessment of small airways is conducted at baseline,including forced expired volume in one second(FEV1),forced vital capacity(FVC),peak expiratory flow(PEF),maximum expiratory flow rate at 75% of vital capacity(MEF75),maximum expiratory flow rate at 50% of vital capacity(MEF50),maximum expiratory flow rate at 25% of vital capacity(MEF25),impulse oscillometry,diffusion function,residual volume(RV) and total lung capacity(TLC).Budesonide(160ug) and formoterol(4.5ug) bid will be given to both groups(chronic obstructive pulmonary disease and asthma-COPD overlap) for 3 months.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ) and chronic obstructive pulmonary disease assessment test(CAT).All of the patients will have a follow-up visit after 3 months' treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 to 80 years-old.
* A diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines are recruited to the chronic obstructive pulmonary disease group.A diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited to the asthma-chronic obstructive pulmonary disease overlap group.
* Willing and able to provide written informed consent.
* Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

* Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions including unstable ischemic heart disease,unstable cardiac arrhythmia or heart failure,life threatening arrhythmias,etc.
* Recent history of chronic obstructive pulmonary disease exacerbation requiring hospitalization or need for increased treatments for chronic obstructive pulmonary disease within 6 weeks.

Primary outcomes:
measure: Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap
timeFrame: 3 months
Secondary outcomes:
measure: Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups
timeFrame: 3 months
measure: Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups
timeFrame: 3 months
measure: Differences of impulse oscillometry parameters between two groups
timeFrame: 3 months
measure: Differences of diffusion function between two groups
timeFrame: 3 months
measure: Differences of residual volume(RV) between two groups
timeFrame: 3 months
measure: Differences of total lung capacity(TLC) between two groups
timeFrame: 3 months
measure: Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Changes of maximum expiratory flow rate at 50% of vital capacity(MEF50) after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Changes of maximum expiratory flow rate at 25% of vital capacity(MEF25) after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Changes of impulse oscillometry parameters(IOS) after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Changes of diffusion function after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Changes of total lung capacity(TLC) after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Changes of residual volume(RV) after 3 months' treatment compared with baseline in both groups
timeFrame: Change from baseline to 3 months
measure: Change of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Change of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Change of chronic obstructive pulmonary disease assessment test(CAT) after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Huapeng Yu
role: PRINCIPAL_INVESTIGATOR
References: