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

Xiuyi Zhi

Status and phase: Unknown; Phase 4

Conditions: Lung Cancer; COPD; Post Operative Complication, Pulmonary

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT02504801

ISSPULR0007

Details and patient eligibility

About

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.

Enrollment: 73 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups, including a placebo group

nebulized Budesonide 2mg/4mL

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide

nebulized saline 4mL

Placebo Comparator group

Description:

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