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

NCT03563001 | Unknown Phase 4

• 1 other identifier: 2016-HXNK-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (16)

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

  3 months

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

  3 months

• Differences of impulse oscillometry parameters between two groups

  3 months

• Differences of diffusion function between two groups

  3 months

• Differences of residual volume(RV) between two groups

  3 months

Study Arms (2)

Chronic Obstructive Pulmonary Disease Group

EXPERIMENTAL

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.

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

Asthma-Chronic Obstructive Pulmonary Disease Overlap Group

EXPERIMENTAL

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.

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

Interventions

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

Also known as: SYMBICORT TURBUHALER

Asthma-Chronic Obstructive Pulmonary Disease Overlap Group; Chronic Obstructive Pulmonary Disease Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome

Interventions

Budesonide; Formoterol Fumarate; BID protein, human; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Asthma; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Huapeng Yu

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huapeng Yu

CONTACT

+86 020-61643888; 359606545@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 20, 2018
• Study Start: June 20, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-05

Locations

CN (1)