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

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

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.

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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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563001


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

Locations
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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
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Principal Investigator: Huapeng Yu Southern Medical University, China

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

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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:
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Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Anti-Asthmatic Agents
Chronic Disease
Undifferentiated Connective Tissue Diseases
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Formoterol Fumarate
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action