CClinicalTrials.gg
Status unknownNCT03551197Updated Jun 20, 2018

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

A Phase 4 interventional study of Budesonide and formoterol bid in Pulmonary Disease, Chronic Obstructive, Exercise and Lung Function Decreased, sponsored by Zhujiang Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-20.

Sponsored by Zhujiang Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

This is a randomized,open-label study to research the changes of lung function before and after exercise in patients with chronic obstructive pulmonary disease .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 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.

02

Conditions studied

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

Keywords

  • Pulmonary Disease, Chronic Obstructive
  • exercise
  • lung function
  • quality of life
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Budesonide and formoterol bid

    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

  • DrugBudesonide and formoterol bid

    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

06

What researchers measure

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.

    Time frame: At resting state and after 6-min walk test

Secondary outcomes

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

    Inspiratory capacity(IC) is measured by Jaeger MasterScreen Pulmonary Function Test System before and after 6-min walk test.

    Time frame: At resting state and after 6-min walk test

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

    Blood oxygen saturation is measured before and after 6-min walk test.

    Time frame: At resting state and after 6-min walk test

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

    Pulse is measured before and after 6-min walk test.

    Time frame: At resting state and after 6-min walk test

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

    At baseline,forced expired volume in one second(FEV1) is measured.After 3 months's treatment of budesonide and formoterol,FEV1 will be measured again.

    Time frame: Change from baseline to 3 months

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

    At baseline,inspiratory capacity(IC) is measured.After 3 months's treatment of budesonide and formoterol,IC will be measured again.

    Time frame: Change from baseline to 3 months

  6. Changes of diffusion function after 3 months' treatment compared with baseline

    At baseline,diffusion function is measured.After 3 months's treatment of budesonide and formoterol,diffusion function will be measured again.

    Time frame: Change from baseline to 3 months

  7. Changes of impulse forced oscillometry parameters after 3 months' treatment compared with baseline

    At baseline,impulse forced oscillometry parameters are measured.After 3 months's treatment of budesonide and formoterol,impulse forced oscillometry parameters will be measured again.

    Time frame: Change from baseline to 3 months

  8. Changes of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline

    At baseline,quality of life is assessed by modified Medical Research Council dyspnoea scale(mMRC).After 3 months's treatment of budesonide and formoterol,the mMRC scores will be measured again.

    Time frame: Change from baseline to 3 months

  9. Changes of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline

    At baseline,quality of life is assessed by St George's Respiratory Questionnaire(SGRQ).After 3 months's treatment of budesonide and formoterol,the SGRQ scores will be measured again.

    Time frame: Change from baseline to 3 months

  10. Changes of clinical chronic obstructive pulmonary questionnaire(CCQ) scores after 3 months' treatment compared with baseline

    At baseline,quality of life is assessed by clinical chronic obstructive pulmonary disease questionnaire(CCQ).After 3 months's treatment of budesonide and formoterol,the scores will be measured again.

    Time frame: Change from baseline to 3 months

  11. Changes of chronic obstructive pulmonary disease assessment test(CAT) scores after 3 months' treatment compared with baseline

    At baseline,quality of life is assessed by chronic obstructive pulmonary disease assessment test(CAT).After 3 months's treatment of budesonide and formoterol,the test will be performed again.

    Time frame: Change from baseline to 3 months

  12. The distance and steps of 6-min walk test

    Both the the distance and steps are measured

    Time frame: Change from baseline to 3 months

07

Study locations

1 of 1 sites recruiting
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03551197
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Jun 11, 2018
Start date
Jun 13, 2018
Primary completion
Sep 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Jun 20, 2018

Study contacts

Huapeng Yu
Contact
359606545@qq.com
+86 020-61643888
Huapeng Yu
principal investigator · Southern Medical University, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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