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

NCT02504801 | Unknown Phase 4 DMC

• 1 other identifier: ISSPULR0007
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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

Keywords

primary lung cancer patients

Outcome Measures

Primary Outcomes (1)

• The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD

  Definition of post-operation pulmonary complication: 1. Pneumonia/other pulmonary infections, with X-ray evidence, fever and/or WBC\>15,000mL 2. Sputum retention:classified as purulent and the pour ability grade is 1 or 2 3. Acute respiratory failture or chronic respiratory failture 4. Atelectasis 5. Aerothorax:\>30% by X-ray; pulmonary embolism

  10 days

Study Arms (2)

nebulized Budesonide 2mg/4mL

ACTIVE COMPARATOR

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

Drug: Budesonide

nebulized saline 4mL

PLACEBO COMPARATOR

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

Interventions

Budesonide 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 Budesonide 2mg/4mL

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \<BMI \< 28

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiuyi Zhi: lead

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Xiuyi Zhi, Professor

CONTACT

8613910086960; hunthm1999@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 22, 2015

Record last verified: 2015-07