Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD

Study Overview
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Brief Summary
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To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.

Official Title
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Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD

Conditions
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Post Operative Complication, Pulmonary, Lung Cancer, COPD

Intervention / Treatment
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* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed or existing COPD defined by GOLD, and FEV1 of<80% predicted and FEV1/FVC<70% Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer .Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer General anesthesia and double cavity intubation was used during operation ASA Classification of Anesthesia Risk is in category 1-3 both in baseline age from 40-80 years old Smoking cessation more than two weeks before operation SP O2>90% before surgery Hemoglobin > 10g/dl Estimated duration of surgery < 4 hours 18.5<BMI < 28 Exclusion Criteria: Patients who had taken systemic corticosteroids in the preceding 1month before baseline Patients who had pneumonia in the preceding 1month before baseline Patients with a history of recent myocardial infarction, heart failure, tuberculosis Subject with known or suspected human immunodeficiency virus infection

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nebulized Budesonide 2mg/4mL<br>+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID | Drug: Budesonide<br>* To test the hypothesis that nebulizer Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two arms among primary lung cancer patients with COPD required single lobectomy from 3 days before operation to 7 days after operation.<br>|
| Placebo Comparator: nebulized saline 4mL<br>+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD | Definition of post-operation pulmonary complication: Pneumonia/other pulmonary infections, with X-ray evidence, fever and/or WBC>15,000mL Sputum retention:classified as purulent and the pour ability grade is 1 or 2 Acute respiratory failture or chronic respiratory failture Atelectasis Aerothorax:>30% by X-ray; pulmonary embolism | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary lung cancer patients