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Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Small Airway Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Budesonide(160ug) and Formoterol(4.5ug) bid

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring chronic obstructive pulmonary disease, asthma-chronic obstructive pulmonary disease overlap, small airway, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chronic Obstructive Pulmonary Disease Group

Asthma-Chronic Obstructive Pulmonary Disease Overlap Group

Arm Description

Patients with diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Disease(GOLD 2018) are recruited.Small airways function of 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.

Patients with 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.Small airways function of 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.

Outcomes

Primary Outcome Measures

Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap

Maximum expiratory flow rate at 75% of vital capacity(MEF75) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Secondary Outcome Measures

Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups

Maximum expiratory flow rate at 50% of vital capacity(MEF50) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups

Maximum expiratory flow rate at 25% of vital capacity(MEF25) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Differences of impulse oscillometry parameters between two groups

Impulse oscillometry parameters are measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Differences of diffusion function between two groups

Diffusion function is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Differences of residual volume(RV) between two groups

Residual volume(RV) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Differences of total lung capacity(TLC) between two groups

Total lung capacity(TLC) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months' treatment compared with baseline in both groups

At baseline,maximum expiratory flow rate at 75% of vital capacity(MEF75) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Changes of maximum expiratory flow rate at 50% of vital capacity(MEF50) after 3 months' treatment compared with baseline in both groups

At baseline,maximum expiratory flow rate at 50% of vital capacity(MEF50) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Changes of maximum expiratory flow rate at 25% of vital capacity(MEF25) after 3 months' treatment compared with baseline in both groups

At baseline,maximum expiratory flow rate at 25% of vital capacity(MEF25) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Changes of impulse oscillometry parameters(IOS) after 3 months' treatment compared with baseline in both groups

At baseline,impulse oscillometry is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Changes of diffusion function after 3 months' treatment compared with baseline in both groups

At baseline,diffusion function is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Changes of total lung capacity(TLC) after 3 months' treatment compared with baseline in both groups

At baseline,total lung capacity(TLC) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Changes of residual volume(RV) after 3 months' treatment compared with baseline in both groups

At baseline,residual volume(RV) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Change of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline

The SGRQ questionnaire is developed to measure the quality of life in patients with chronic airway diseases.Scores range from 0 to 100,higher scores indicates worse respiratory condition.The St George's Respiratory Questionnaire is performed in both groups at baseline.After 3 months's treatment of budesonide and formoterol,the scores will be measured again.

Change of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline

The mMRC scale is used to assess the degree of breathlessness.The scores range from 0 to 4,higher scores indicates more serious respiratory condition.The mMRC is performed in both groups at baseline.After 3 months's treatment of budesonide and formoterol,the scores will be measured again.

Change of chronic obstructive pulmonary disease assessment test(CAT) after 3 months' treatment compared with baseline

The CAT test is used to assess the impact of COPD on patients' daily life.The scores range from 0 to 40,higher scores indicates worse respiratory condition.The CAT test is performed in both groups at baseline.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Full Information

NCT ID

NCT03563001

First Posted

May 23, 2018

Last Updated

June 25, 2018

Sponsor

Zhujiang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03563001

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 20, 2018 (Actual)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chronic Obstructive Pulmonary Disease Group

Arm Type

Experimental

Arm Description

Arm Title

Asthma-Chronic Obstructive Pulmonary Disease Overlap Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Budesonide(160ug) and Formoterol(4.5ug) bid

Other Intervention Name(s)

SYMBICORT TURBUHALER

Intervention Description

For both groups of subjects,small airways function of 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 Outcome Measure Information:

Title

Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap

Description

Maximum expiratory flow rate at 75% of vital capacity(MEF75) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups

Description

Maximum expiratory flow rate at 50% of vital capacity(MEF50) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Title

Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups

Description

Maximum expiratory flow rate at 25% of vital capacity(MEF25) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Title

Differences of impulse oscillometry parameters between two groups

Description

Impulse oscillometry parameters are measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Title

Differences of diffusion function between two groups

Description

Diffusion function is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Title

Differences of residual volume(RV) between two groups

Description

Residual volume(RV) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Title

Differences of total lung capacity(TLC) between two groups

Description

Total lung capacity(TLC) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.

Time Frame

3 months

Title

Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months' treatment compared with baseline in both groups

Description

At baseline,maximum expiratory flow rate at 75% of vital capacity(MEF75) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.

Time Frame