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Efficacy and safety of tiotropium bromide combined with budesonide/formoterol in the treatment of moderate to severe chronic obstructive pulmonary disease

Efficacy and safety of tiotropium bromide combined with budesonide/formoterol in the treatment of moderate to severe chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017584
Enrollment
Unknown
Registered
2018-08-05
Start date
2014-01-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Moderate to severe chronic obstructive pulmonary disease

Interventions

Intervention group:Budesonide/formoterol (Symbicort
160 µg/4.5 µg
1 suction/time, 2 times/day)
treatment of tiotropium bromide (Spiriva
1.8 µg inhaled once a day before sleeping).
Control group:Bbudesonide/formoterol (Symbicort
1 suction/time, 2 times/day).

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged >18 years; patients who were diagnosed with group B and C COPD in accordance with the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (revised edition from 2013), published by the COPD Group of the Chinese Thoracic Society; patients who received inhalation therapy; patients who didnt receive any cholinolytic drugs within 4 weeks; patients who didnt suffer from any acute attack and didnt receive any antibiotic therapy within 4 weeks; patients who had not received any systemic glucocorticoid therapy in the past two months; patients who provided written informed consent.

Exclusion criteria

Exclusion criteria: Patients who were allergic to tiotropium bromide, budesonide/formoterol inhalation or any other inhaled ingredients; patients with diseases rendering them unsuitable for inhalation therapy, including bronchial lung cancer, dilatation and interstitial lung diseases; patients suffering from other systemic diseases, including heart, liver, kidney, hematopoietic and nervous system diseases, glaucoma or severe prostatic hyperplasia; patients who were considered unsuitable for participating in the drug trial by the clinicians.

Design outcomes

Primary

MeasureTime frame
Lung function;Body mass index;The dyspnea score;The six-minute walking test;Health-associated quality of life;Prognosis and safety indices;

Countries

China

Contacts

Public ContactHua Xu

The First Affiliated Hospital of Soochow University

xuhua9056@163.com+86 512-67973261

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026