Status:
UNKNOWN
Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
72 patients with mild to moderate chronic obstructive pulmonary disease were planned to be enrolled in this study and then treated with olodaterol combined with thiotropium bromide, and thiotropium br...
Detailed Description
Studies have confirmed that thiotropium bromide combined with olodaterol can significantly improve airway inflammation, quality of life and pulmonary function in patients with stable COPD, without sig...
Eligibility Criteria
Inclusion
- Male or female, aged ≥ 40 years;
- Meet the diagnostic criteria of COPD, and GOLD grade I - II;
- FEV1/FVC \< 70% and FEV1 ≥ 50% of the expected value after the use of bronchodilators;
- Patients must be able to complete all study-related steps, voluntarily participate in this study and sign the informed consen.
Exclusion
- Patients with asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary embolism, bronchiolitis obliterans, paradoxical bronchospasm;
- Patients with blood eosinophilia;
- Patients with upper respiratory tract infection;
- Patients with liver or renal insufficiency;
- Patients with severe unstable systemic diseases or malignant tumors;
- Patients with glaucoma, benign prostatic hyperplasia or bladder neck obstruction;
- Patients with hypokalemia, hyperglycemia, diabetes, ketoacidosis or other serious systemic diseases such as heart, brain, liver, kidney, digestive system, endocrine system, immune system, blood;
- Women of childbearing age who are pregnant, lactating or plan to become pregnant;
- Patients who have undergone previous pneumonectomy or received lung volume reduction surgery within 12 months before screening;
- Patients with mental illness;
- Patients who have participated in other clinical trials within 3 months before screening;
- Allergic constitution or known allergy to atropine or its derivatives (such as isopropylamine or oxytoluium) Or those who are allergic to the intervention drugs and their ingredients;
- The researchers believe that it is not appropriate to participate in this clinical trial.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05295355
Start Date
January 25 2021
End Date
March 1 2025
Last Update
October 21 2022
Active Locations (1)
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1
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, China, 510000