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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02504801
• Other study ID #: ISSPULR0007
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 15, 2015
• Last updated: July 20, 2015
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2015
• Source: Xuanwu Hospital, Beijing
• Contact: Xiuyi Zhi, Professor
• Phone: 8613910086960
• Email: hunthm1999[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 73
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• COPD
• Lung Cancer
• Lung Neoplasms
• Post Operative Complication, Pulmonary
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiuyi Zhi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No