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

NCT ID: NCT03563001

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2018-09-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Small Airway Disease; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic Obstructive Pulmonary Disease Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Asthma-Chronic Obstructive Pulmonary Disease Overlap Group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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

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.

Intervention Type: DRUG

Other Intervention Names

SYMBICORT TURBUHALER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huapeng Yu

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huapeng Yu

Role: CONTACT

359606545@qq.com

+86 020-61643888

Facility Contacts

Huapeng Yu

Role: primary

359606545@qq.com

+86 020-61643888

Other Identifiers

2016-HXNK-002

Identifier Type: -

Identifier Source: org_study_id