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Salvational Intervention for Reducing AECOPD Under Severe Air Pollution

NCT03083067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-03-31

No results posted yet for this study

Summary

This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial.A total of 764 stable COPD patients according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group).On the foundation of basic medicine, inhaled ICS/LABA will be used as an intervention drug for patients in SI group on severe air pollution days. It is aimed to evaluate whether this novel treatment strategy will decrease the frequency of AECOPD per year.

Conditions

  • COPD Exacerbation
  • Air Pollution

Interventions

DRUG

Budesonide/formoterol

On the foundation of basic treatment strategies, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in PIC group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200.

DRUG

tiotropium bromide

Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.

Sponsors & Collaborators

  • Peking University Shougang Hospital

    collaborator OTHER

  • People's Hospital of Beijing Daxing District

    collaborator OTHER

  • Beijing Jingmei Group General Hospital

    collaborator UNKNOWN

  • Beijing Miyun Hospital

    collaborator UNKNOWN

  • The Hospital of Shunyi District Beijing

    collaborator UNKNOWN

  • Beijing Luhe Hospital

    collaborator OTHER

  • Civil Aviation General Hospital

    collaborator OTHER

  • Beijing Jishuitan Hospital

    collaborator OTHER

  • Aerospace 731 Hospital

    collaborator OTHER

  • Beijing Changping Hospital

    collaborator UNKNOWN

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Guangfa Wang, MD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2022-03-16
Completion
2022-03-16

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083067 on ClinicalTrials.gov