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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02504801

Enrollment

Registered

2015-07-22

Start date

2015-07-31

Completion date

2016-10-31

Last updated

2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Lung Cancer, Post Operative Complication, Pulmonary

Keywords

primary lung cancer patients

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.

Interventions

DRUGBudesonide

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD	10 days	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

Contacts

Primary ContactXiuyi Zhi, Professor

hunthm1999@163.com8613910086960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026