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

• ClinicalTrials.gov Identifier: NCT03563001
• Recruitment Status: Unknown
• First Posted: June 20, 2018
• Last Update Posted: June 27, 2018
• Sponsor: Zhujiang Hospital
• Information provided by (Responsible Party): Zhujiang Hospital

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Small Airway Disease; Quality of Life	Drug: Budesonide(160ug) and Formoterol(4.5ug) bid	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
• Actual Study Start Date: June 20, 2018
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Name: SYMBICORT TURBUHALER
Experimental: 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.	Drug: 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.; Other Name: SYMBICORT TURBUHALER

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 3 months ]
   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 :

1. Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups [ Time Frame: 3 months ]
   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.
2. Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups [ Time Frame: 3 months ]
   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.
3. Differences of impulse oscillometry parameters between two groups [ Time Frame: 3 months ]
   Impulse oscillometry parameters are measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
4. Differences of diffusion function between two groups [ Time Frame: 3 months ]
   Diffusion function is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
5. Differences of residual volume(RV) between two groups [ Time Frame: 3 months ]
   Residual volume(RV) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
6. Differences of total lung capacity(TLC) between two groups [ Time Frame: 3 months ]
   Total lung capacity(TLC) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
7. Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
   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.
8. Changes of maximum expiratory flow rate at 50% of vital capacity(MEF50) after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
   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.
9. Changes of maximum expiratory flow rate at 25% of vital capacity(MEF25) after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
   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.
10. Changes of impulse oscillometry parameters(IOS) after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
    At baseline,impulse oscillometry is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
11. Changes of diffusion function after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
    At baseline,diffusion function is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
12. Changes of total lung capacity(TLC) after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
    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.
13. Changes of residual volume(RV) after 3 months' treatment compared with baseline in both groups [ Time Frame: Change from baseline to 3 months ]
    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.
14. Change of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline [ Time Frame: Change from baseline to 3 months ]
    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.
15. Change of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline [ Time Frame: Change from baseline to 3 months ]
    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.
16. Change of chronic obstructive pulmonary disease assessment test(CAT) after 3 months' treatment compared with baseline [ Time Frame: Change from baseline to 3 months ]
    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.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Huapeng Yu; +86 020-61643888; 359606545@qq.com

Locations

China, Guangdong

Zhujiang Hospital of Southern Medical University; Recruiting

Guangzhou, Guangdong, China

Contact: Huapeng Yu +86 020-61643888 359606545@qq.com

Sponsors and Collaborators

Zhujiang Hospital

Investigators

• Principal Investigator: Huapeng Yu; Southern Medical University, China

More Information

• Responsible Party: Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT03563001
• Other Study ID Numbers: 2016-HXNK-002
• First Posted: June 20, 2018
• Last Update Posted: June 27, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:

chronic obstructive pulmonary disease; asthma-chronic obstructive pulmonary disease overlap; small airway; quality of life

Additional relevant MeSH terms:

Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Budesonide; Formoterol Fumarate; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action