Change of Lung Function After Exercise in Patients With Chronic Obstructive Pulmonary Disease

NCT03551197 | Unknown Phase 4

• 1 other identifier: 2018-HXNK-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the changes of lung function before and after the exercise in patients with chronic obstructive pulmonary disease.The assessment of quality of life is also carried out through questionnaires.

Conditions

Pulmonary Disease, Chronic Obstructive; Exercise; Lung Function Decreased; Quality of Life

Keywords

Pulmonary Disease, Chronic Obstructive; exercise; lung function; quality of life

Outcome Measures

Primary Outcomes (1)

• Changes of forced expired volume in one second(FEV1) after 6-min walk test compared with resting state

  Forced expired volume in one second(FEV1) is measured by Jaeger MasterScreen Pulmonary Function Test System before and after 6-min walk test.

  At resting state and after 6-min walk test

Secondary Outcomes (12)

• Changes of inspiratory capacity(IC) after 6-min walk test compared with resting state

  At resting state and after 6-min walk test

• Changes of blood oxygen saturation after 6-min walk test compared with resting state

  At resting state and after 6-min walk test

• Changes of pulse after 6-min walk test compared with resting state

  At resting state and after 6-min walk test

• Changes of forced expired volume in one second(FEV1) after 3 months' treatment compared with baseline

  Change from baseline to 3 months

• Changes of inspiratory capacity(IC) after 3 months' treatment compared with baseline

  Change from baseline to 3 months

Study Arms (1)

Budesonide and formoterol bid

EXPERIMENTAL

At baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ),clinical chronic obstructive pulmonary questionnaire(CCQ) and chronic obstructive pulmonary disease assessment test(CAT).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 all the examinations mentioned above after 3 months' treatment.

Drug: Budesonide and formoterol bid

Interventions

Budesonide and formoterol bid DRUG

At baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ),clinical chronic obstructive pulmonary questionnaire(CCQ) and chronic obstructive pulmonary disease assessment test(CAT).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 all the examinations mentioned above after 3 months' treatment.

Also known as: SYMBICORT TURBUHALER

Budesonide and formoterol bid

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, inclusive.
• A clinical diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines.
• Post bronchodilator (following inhalation of salbutamol) forced expired volume in one second(FEV1)/forced vital capacity(FVC) ratio ≤0.70.
• 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; Motor Activity; Respiratory Insufficiency

Interventions

Budesonide; 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; Behavior; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is only one group.Patients with diagnosis of Chronic Obstructive Pulmonary Disease are recruited.Subjects will be examined at baseline and after 3 months' treatment of budesonide and formoterol.

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 11, 2018
• Study Start: June 13, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-05

Locations

CN (1)