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

NCT ID: NCT02504801

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-10-31

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.

Conditions

Post Operative Complication, Pulmonary; Lung Cancer; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

nebulized Budesonide 2mg/4mL

+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID

Group Type: ACTIVE_COMPARATOR

Budesonide

Intervention Type: DRUG

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.

nebulized saline 4mL

+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiuyi Zhi

OTHER

Sponsor Role: lead

Responsible Party

Xiuyi Zhi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Xiuyi Zhi, Professor

Role: CONTACT

hunthm1999@163.com

8613910086960

Other Identifiers

ISSPULR0007

Identifier Type: -

Identifier Source: org_study_id