Clinical study of TCM delaying adverse progression in patients with COPD at stable stage (GOLD stage 0-2)

Phase 1

Recruiting

• Conditions: Stable stage of chronic obstructive pulmonary disease (GOLD stage 0-2)

• Registration Number: ITMCTR2000003919
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Stable patients clinically diagnosed as COPD GOLD stage 0-2;In line with TCM lung spleen qi deficiency syndrome;
2. There was no history of acute exacerbation in the first 4 weeks of randomization;
3. Successful pulmonary function measurement;
4. The patient was informed and signed a written consent.

Exclusion Criteria

1. The subject is pregnant, breastfeeding or planning to become pregnant;
2. Active pulmonary infection <= 4 weeks after completion of antibiotic and/or steroid therapy or prior pulmonary infection.
3. Combined with other known serious lung diseases, including active tuberculosis, clinically significant bronchiectasis, bronchial asthma, lung cancer, pneumothorax, etc.;
4. Patients with type 1 or type 2 diabetes;
5. Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder neck obstruction or severe renal impairment or urinary retention.Stable treatment in patients with benign prostatic hyperplasia (BPH) may be considered for inclusion.
6. Patients with severe primary diseases such as heart, liver, kidney and hematopoietic system, mental illness or any other disease that may threaten the safety of patients, interfere with the evaluation or hinder the completion of the study;
7. A patient who is allergic to any study drug or similar chemically classified drug;
8. Patients unable to successfully use dry powder inhalers or unable to perform pulmonary function measurements;
9. Are participating in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1;FEV1 / FVC % expected value;Fev1% expected value case;FVC;

Secondary Outcome Measures

Name	Time	Method
CCQ;mMRC;TCM symptom score scale;CAT;SGRQ;