Clinical Trials Logo
  1. Home
  2. Air Pollution
  3. NCT03083067

Salvational Intervention for Reducing AECOPD Under Severe Air Pollution — SIRCAP  

COPD Exacerbation Clinical Trial

Official title:
A Prospective Study of Salvational Intervention With ICS/LABA for Reducing Chronic Obstructive Pulmonary Disease Exacerbation Under Severe Air Pollution (SIRCAP) in Beijing

Clinical Trial 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.

Clinical Trial Description

This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial. A total of 764 stable COPD patients with history of exacerbation according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group). The randomization is stratified by medical center and the random code is designed in a 1:1 ratio. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 10 units participating in the study include Peking University Shougang Hospital, People's Hospital of Beijing Daxing District, Beijing Jingmei Group General Hospital, Beijing Miyun Hospital, Beijing Changping Hospital, The Hospital of Shunyi District Beijing, Beijing Luhe Hospital Capital Medical University, Civil Aciation General Hospital, Beijing Jishuitan Hospital and Aerospace 731 Hospital. These 11 centers approximately cover area from urban to suburbs in Beijing. Inhaled tiotropium bromide(18ug), budesonide/formoterol（160ug/4.5ug）or tiotropium bromide(18ug)+ budesonide/formoterol （160ug/4.5ug）will be used as basic medicine. On the foundation of basic medicine, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in SI 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. CT group maintains the original treatment. Besides baseline, patients will be formally visited 4 or 5 times during this trial: before randomization (for those who need pharmacological washout) and every six months after randomization. Primary outcome is the frequency of AECOPD per year, which is defined as the frequency of AECOPD/the number of patients/year. Secondary outcomes include the number of unplanned outpatient visits, emergency medical visits, hospitalization, medical expense and mortality caused by AECOPD per year. The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2016[1032]). Any protocol modifications will be submitted for the IRB review and approval. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03083067
Study type Interventional
Source Peking University First Hospital
Contact
Status Completed
Phase N/A
Start date March 20, 2017
Completion date March 16, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06000696 - Healthy at Home Pilot
Recruiting NCT03250000 - Changes in Microcirculation and Functional Status During Exacerbation of COPD N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Recruiting NCT06118632 - Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A
Completed NCT04170361 - The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Not yet recruiting NCT03296215 - Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals N/A
Completed NCT03003702 - Domiciliary Monitoring to Predict Exacerbations of COPD N/A
Completed NCT02912689 - NIV - NAVA vs NIV - PS for COPD Exacerbation N/A
Recruiting NCT02264483 - Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile. N/A
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Recruiting NCT02065921 - Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I
Recruiting NCT04638920 - Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy
Not yet recruiting NCT05897125 - Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients N/A