Trial | NCT02504801  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    budesonide ...

  • Study Participants

    73
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 Started
Jul 31
2015
Primary Completion
Jul 31
2016
Anticipated
Study Completion
Oct 31
2016
Anticipated
Last Update
Jul 22
2015
Estimate

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.

nebulized Budesonide 2mg/4mL Active Comparator

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

nebulized saline 4mL Placebo Comparator

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Patients who had taken systemic corticosteroids in the preceding 1month before baseline
Patients who had pneumonia in the preceding 1month before baseline
Patients with a history of recent myocardial infarction, heart failure, tuberculosis
Subject with known or suspected human immunodeficiency virus infection
No Results Posted