Back to resultsEfficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD
Primary Purpose
Post Operative Complication, Pulmonary, Lung Cancer, COPD
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Budesonide
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Complication, Pulmonary focused on measuring primary lung cancer patients
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
nebulized Budesonide 2mg/4mL
nebulized saline 4mL
Arm Description
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504801
Brief Title
Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD
Official Title
Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiuyi Zhi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Complication, Pulmonary, Lung Cancer, COPD
Keywords
primary lung cancer patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nebulized Budesonide 2mg/4mL
Arm Type
Active Comparator
Arm Description
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID
Arm Title
nebulized saline 4mL
Arm Type
Placebo Comparator
Arm Description
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD
Description
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
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuyi Zhi, Professor
Phone
8613910086960
Email
hunthm1999@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD
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