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A 12-month, multicenter, randomized, double-blind, parallel controlled trial for assessment of the short-term effect and long-term prognosis of early antibiotic therapy in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) without significant signs of infection.

A 12-month, multicenter, randomized, double-blind, parallel controlled trial for assessment of the short-term effect and long-term prognosis of early antibiotic therapy in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) without significant signs of infection.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018921
Enrollment
Unknown
Registered
2018-10-16
Start date
2018-10-20
Completion date
Unknown
Last updated
2018-10-22

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

Conditions

AECOPD

Interventions

Group A:Moxifloxacin 400mg per day for 7 days
Group B:Same amount of saline without moxifloxacin for 7 days

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 40-70 years; 2. Patients with AECOPD (patients complained of symptoms of sudden changes (baseline dyspnea, cough, and/or sputum) more than the daily variation range of patients with COPD (always check lung function: with bronchial relaxation, FEV1 / FVC < 0.70)); 3. The subjects should be volunteers and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with pulmonary infection (any of four signs: Fever; Recent symptoms of cough and purulent; Peripheral blood white blood cells >10 x 10^9/L or 400pg/ml); 3. Patients with AECOPD in a critical condition, in which the auxiliary breathing muscles participate in respiratory movement, chest and abdomen contradictory breathing, cyanosis, and invasive mechanical ventilation are required; 4. Patients with concomitant signs of lower limb edema, right heart failure and hemodynamic instability; 5. Patients with merge spiritual changes; 6. Patients with malignant tumors or other serious diseases; 7. Moxifloxacin allergy sufferers.

Design outcomes

Primary

MeasureTime frame
clinical symptoms;pulmonary function test;blood routine examination;Serum inflammatory markers;

Secondary

MeasureTime frame
blood gas analysis;FeNO;phlegma;Echocardiography;CT Scan of the Lungs;Rating scales;Medication;

Countries

China

Contacts

Public ContactLiu Huiguo

Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

liuhuiguotj@139.com+86 13871014148

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026