Clinical trial NCT03428412: Effects of Traditional Chinese Medicine on AECOPD Patients
Official title: Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Acute Exacerbation
Medicine, Chinese Traditional
Keywords: Chronic Obstructive Pulmonary Disease
Acute exacerbation
Traditional Chinese medicine
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 378
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).


Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of moderate to very severe AECOPD
* Age between 40 and 80 years
* Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
* Without participations in other interventional trials in the previous one month
* With the informed consent signed

Exclusion Criteria:

* Pregnant and lactating women
* Dementia, mental disorders and reluctant partners
* Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics
* Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function)
* Combined tumor
* Treated outside the hospital for more than 7 days
* Need to carry out invasive mechanical ventilation respiratory failure
* Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation)
* Bedridden for various reasons
* Allergic to the used medicine

Primary outcomes:
measure: COPD Assessment Test(CAT)
timeFrame: Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.
Secondary outcomes:
measure: Treatment failure rate
timeFrame: The numbers of treatment failure at day 14 of the treatment phase.
measure: Treatment success rate
timeFrame: The numbers of treatment success at day 14 of the treatment phase.
measure: Length of hospital stays
timeFrame: The length hospital stays in 14 Days of the treatment phase
measure: Readmission due to AECOPD
timeFrame: The numbers of readmission due to AECOPD in 28 Days of the followup phase.
measure: Intubation rate
timeFrame: The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.
measure: Mortality
timeFrame: The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.
measure: Dyspnea
timeFrame: Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase.
measure: SF-36
timeFrame: Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
measure: COPD-PRO
timeFrame: Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang H, Li J, Yu X, Li S, Wang H, Ruan H, Si Y, Xie Y, Wang M. Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):735. doi: 10.1186/s13063-019-3772-y.