Astragalus-containing compound formula for stable chronic obstructive pulmonary disease with a focus on relatively younger patients: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
- 1Tianjin Medical University, Tianjin, China.
- 2Department of Respiratory and Critical Care Medicine, Tianjin Fourth Central Hospital, The Affiliated Hospital of Tianjin Medical University, Tianjin, China.
- 3Tianjin University, Tianjin, China.
Abstract
Chronic obstructive pulmonary disease (COPD) increasingly affects relatively younger, working-age adults, in whom impaired physical function can compromise work, family responsibilities, and quality of life. This study aims to evaluate the efficacy and safety of an Astragalus-containing compound formula as an adjunct to protocol-specified background Western maintenance therapy in patients with stable COPD, with particular interest in its effects among relatively younger, working-age patients. This multicenter, randomized, double-blind, placebo-controlled trial includes patients aged 40-75 years with stable COPD, Global Initiative for Chronic Obstructive Lung Disease grades 2-4, at least two moderate exacerbations or one exacerbation-related hospitalization during the previous 12 months, and the traditional Chinese medicine (TCM) pattern of lung-kidney qi deficiency. An exploratory age-focused analysis will evaluate participants aged 40-60 years. The intervention is a fixed 12-herb Astragalus-containing compound formula. Eligible participants must have received one of the protocol-specified stable-dose inhaled maintenance regimens for at least 3 consecutive months before screening. Participants are centrally randomized 1:1 through an Interactive Web Response System (IWRS), with stratification by study center, to receive either a fixed 12-herb Astragalus-containing compound formula or matching placebo for 48 weeks in addition to background therapy. Primary outcomes are acute exacerbation frequency, lung function assessed by forced expiratory volume in one second, forced vital capacity, and their ratio, and physical fitness assessed by six-minute walk distance (6MWD), muscle strength, flexibility, and balance. Secondary outcomes include the modified Medical Research Council (mMRC) dyspnea scale, COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), TCM syndrome score, and Epworth Sleepiness Scale (ESS). Assessments will be conducted at baseline and at weeks 4, 12, 24, 36, and 48. Primary efficacy analyses will be conducted in the full analysis set (FAS), following the intention-to-treat (ITT) principle, using prespecified negative binomial regression and linear mixed-effects models, with per-protocol (PP) analyses performed as sensitivity analyses. This trial is designed to evaluate whether the compound formula provides additional long-term benefits in reducing exacerbations and improving physical function in relatively younger and working-age patients with stable COPD. Drug Clinical Trial Registration and Information Disclosure Platform of the National Medical Products Administration (NMPA), China, registration No. CTR20232692.
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BibTeX
@article{hao2026astragaluscontaining,
title = {{Astragalus-containing compound formula for stable chronic obstructive pulmonary disease with a focus on relatively younger patients: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.}},
author = {Luping Hao and Rong Cui and Qiuchan Wang and Dajun Liu and Qiufeng Peng and Jingchun He},
journal = {Journal of thoracic disease},
year = {2026},
month = sep,
doi = {10.21037/jtd-2026-0794},
url = {https://europepmc.org/article/MED/42996950},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Astragalus-containing compound formula for stable chronic obstructive pulmonary disease with a focus on relatively younger patients: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
AU - Luping Hao
AU - Rong Cui
AU - Qiuchan Wang
AU - Dajun Liu
AU - Qiufeng Peng
AU - Jingchun He
PY - 2026
DA - 2026/09/28
JO - Journal of thoracic disease
DO - 10.21037/jtd-2026-0794
UR - https://europepmc.org/article/MED/42996950
AB - Chronic obstructive pulmonary disease (COPD) increasingly affects relatively younger, working-age adults, in whom impaired physical function can compromise work, family responsibilities, and quality of life. This study aims to evaluate the efficacy and safety of an Astragalus-containing compound formula as an adjunct to protocol-specified background Western maintenance therapy in patients with stable COPD, with particular interest in its effects among relatively younger, working-age patients. This multicenter, randomized, double-blind, placebo-controlled trial includes patients aged 40-75 years with stable COPD, Global Initiative for Chronic Obstructive Lung Disease grades 2-4, at least two moderate exacerbations or one exacerbation-related hospitalization during the previous 12 months, and the traditional Chinese medicine (TCM) pattern of lung-kidney qi deficiency. An exploratory age-focused analysis will evaluate participants aged 40-60 years. The intervention is a fixed 12-herb Astragalus-containing compound formula. Eligible participants must have received one of the protocol-specified stable-dose inhaled maintenance regimens for at least 3 consecutive months before screening. Participants are centrally randomized 1:1 through an Interactive Web Response System (IWRS), with stratification by study center, to receive either a fixed 12-herb Astragalus-containing compound formula or matching placebo for 48 weeks in addition to background therapy. Primary outcomes are acute exacerbation frequency, lung function assessed by forced expiratory volume in one second, forced vital capacity, and their ratio, and physical fitness assessed by six-minute walk distance (6MWD), muscle strength, flexibility, and balance. Secondary outcomes include the modified Medical Research Council (mMRC) dyspnea scale, COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), TCM syndrome score, and Epworth Sleepiness Scale (ESS). Assessments will be conducted at baseline and at weeks 4, 12, 24, 36, and 48. Primary efficacy analyses will be conducted in the full analysis set (FAS), following the intention-to-treat (ITT) principle, using prespecified negative binomial regression and linear mixed-effects models, with per-protocol (PP) analyses performed as sensitivity analyses. This trial is designed to evaluate whether the compound formula provides additional long-term benefits in reducing exacerbations and improving physical function in relatively younger and working-age patients with stable COPD. Drug Clinical Trial Registration and Information Disclosure Platform of the National Medical Products Administration (NMPA), China, registration No. CTR20232692.
SN - 2072-1439
SN - 2077-6624
ER -