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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer; COPD; Post Operative Complication, Pulmonary
• Intervention / Treatment: Drug: Budesonide

• Study Type: Interventional
• Enrollment (Anticipated): 73
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nebulized Budesonide 2mg/4mL; +terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID	Drug: Budesonide; 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.
Placebo Comparator: nebulized saline 4mL; +terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiuyi Zhi

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: primary lung cancer patients
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Postoperative Complications; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: ISSPULR0007