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A randomized controlled trial for effects of Zheng's multi-function device for respiratory rehabilitation on ventilation and sputum symptom in AECOPD patients

A randomized controlled trial for effects of Zheng's multi-function device for respiratory rehabilitation on ventilation and sputum symptom in AECOPD patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021423
Enrollment
Unknown
Registered
2019-02-21
Start date
2017-09-01
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbation of chronic obstructive pulmonary

Interventions

Control group:Nebulized saline
Drug group:Atomized ambroxol hydrochloride
Multi-function device group:multi-function device excise
Combination group:Atomized ambroxol hydrochloride and multi-function device excise

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
51 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria can be enrolled: 1) Meet the lower respiratory tract infections (such as acute exacerbation of chronic bronchitis, pneumonia, acute exacerbation of chronic obstructive pulmonary disease, bronchiectasis without hemoptysis, etc.) clinical diagnostic criteria; 2) Must have symptoms of adhesion (sputum trait score = 2 points), symptoms of cough difficulty (cough difficulty score = 2 points), 24h sputum = 10ml and other clinical symptoms; 3) Hospitalized patients; 4) Aged 18 to 80 years, gender is not limited; 5) The subject has fully understood and voluntarily signed the informed consent form; 6) The Zheng's multi-function device can be used correctly.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will not be allowed to participate in the study: 1) Those who are known to be allergic to the test drug ingredients and pharmaceutical excipients; 2) Only patients with upper respiratory tract infection; 3) Patients with bronchiectasis with hemoptysis, pneumothorax, severe pulmonary hypertension, severe pulmonary infection requiring ICU therapy, active tuberculosis, tuberculous pleurisy, and severe respiratory failure requiring 24 hours of ventilator-assisted therapy; 4) Patients who are unable to cooperate with nebulization therapy or physical drainage, can not correctly use Zheng's respiratory valve, and chest imaging indicates the presence of pulmonary bullae with a diameter of more than 8cm; 5) Take Chinese medicine and western medicine, such as antitussive and expectorant drugs, which improve the symptoms of lower respiratory tract infections, except for the research drug, within 1 day before the first dose (24h). 6) Previously or currently combined with any of the following major diseases: a history of cerebrovascular accidents within the last 3 months, such as ischemic stroke and hemorrhagic stroke; unstable angina, myocardial infarction within the last 3 months, History of heart failure; inability to cough up sputum; large aneurysm or dissection aneurysm; percutaneous transluminal coronary angioplasty or cardiac surgery; severe liver disease or liver dysfunction; severe nephropathy; severe hematopoiesis Systemic primary disease or agranulocytosis patients. 7) Before entering the group, any laboratory inspection indicators meet the following criteria: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times the upper limit of normal; serum creatinine value (Cr) > 1.5 times the upper limit of normal; 8) Other situations that are not suitable for participation in the study: Those who have participated in or are participating in other researchers one month before screening; have a history of drug use, alcohol or drug abuse; those who have serious neurological and psychiatric disorders who cannot fully understand and cooperate; pregnant women who are pregnant, breastfeeding, and planning to become pregnant Or male patients; unable to comply with the requirements of the study protocol; the investigator believes that there are other circumstances that are not suitable for clinical trials. 9) Patients who are considered unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Amount of sputum;

Countries

China

Contacts

Public ContactZheng Zeguang

The First Affiliated Hospital of Guangzhou Medical University

zheng8620@139.com+86 18928868242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026