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

Phase 4

• Conditions: Post Operative Complication, Pulmonary; Lung Cancer; COPD
• Interventions: Drug: Budesonide

• Registration Number: NCT02504801
• Lead Sponsor: Xiuyi Zhi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-20
• Last Update Submitted: 2015-07-20
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22
• Primary Completion: 2016-07
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. Newly diagnosed or existing COPD defined by GOLD, and FEV1 of<80% predicted and FEV1/FVC<70%
2. Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer
3. .Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer
4. General anesthesia and double cavity intubation was used during operation
5. ASA Classification of Anesthesia Risk is in category 1-3 both in baseline
6. age from 40-80 years old
7. Smoking cessation more than two weeks before operation
8. SP O2>90% before surgery
9. Hemoglobin > 10g/dl
10. Estimated duration of surgery < 4 hours
11. 18.5<BMI < 28

Exclusion Criteria

1. Patients who had taken systemic corticosteroids in the preceding 1month before baseline
2. Patients who had pneumonia in the preceding 1month before baseline
3. Patients with a history of recent myocardial infarction, heart failure, tuberculosis
4. Subject with known or suspected human immunodeficiency virus infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nebulized Budesonide 2mg/4mL	Budesonide	+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID

Primary Outcome Measures

Name	Time	Method
The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD	10 days	Definition of post-operation pulmonary complication: 1. Pneumonia/other pulmonary infections, with X-ray evidence, fever and/or WBC\>15,000mL; 2. Sputum retention:classified as purulent and the pour ability grade is 1 or 2; 3. Acute respiratory failture or chronic respiratory failture; 4. Atelectasis; 5. Aerothorax:\>30% by X-ray; pulmonary embolism