Skip to content

Efficacy and cardiovascular adverse effects of Long-acting inhaled dual bronchodilation

Efficacy and cardiovascular adverse effects of Long-acting inhaled dual bronchodilation

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043128
Enrollment
Unknown
Registered
2021-02-05
Start date
2021-01-31
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

QVA149:receive QVA149 110/50 mg
Tiotropium:receive Tiotropium 18 µg

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. To conform to the diagnostic and grading criteria on pulmonary function: a post-bronchodilator forced expiratory volume in 1 s (FEV1) < 80% of the predicted normal, and post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of < 0.70 at screening. b. To conform to the criteria on Groups B (low risk, more symptoms), C (high risk, fewer symptoms), D (high risk, more symptoms) in the ABCD assessment scheme of Global Initiative for Chronic Obstructive Lung Disease (GOLD). c. Participants were in the COPD stabilization period when they were included in the study. d. The long-term inhalation regimen for patients is QVA149 110/50 µg or Tiotropium 18 µg.

Exclusion criteria

Exclusion criteria: clinically significant cardiovascular (CV) conditions including severe heart failure (EF<30%), myocardial infarction, malignant arrhythmia; Use of ß-receptor Blocking Drugs was not permitted.

Design outcomes

Primary

MeasureTime frame
pulmonary function;Electrocardiogram;Cardiac ultrasound;Cardiac function, Including: AST, CK, CK-MB,LDH, a-HBDH, CTNI;Blood pressure;

Countries

China

Contacts

Public ContactLing Xiao

The First Affiliated Hospital of Shantou University Medical College

xling108@163.com+86 13546892996

Outcome results

None listed

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