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

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ClinicalTrials.gov Identifier: NCT02504801
Recruitment Status : Unknown
Verified July 2015 by Xiuyi Zhi, Xuanwu Hospital, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Xiuyi Zhi, Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Post Operative Complication, Pulmonary Lung Cancer COPD Drug: Budesonide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : July 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Budesonide

Arm Intervention/treatment
Active Comparator: nebulized Budesonide 2mg/4mL
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID
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.

Placebo Comparator: nebulized saline 4mL
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID



Primary Outcome Measures :
  1. The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD [ Time Frame: 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504801


Contacts
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Contact: Xiuyi Zhi, Professor 8613910086960 hunthm1999@163.com

Sponsors and Collaborators
Xiuyi Zhi

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Responsible Party: Xiuyi Zhi, Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02504801     History of Changes
Other Study ID Numbers: ISSPULR0007
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by Xiuyi Zhi, Xuanwu Hospital, Beijing:
primary lung cancer patients
Additional relevant MeSH terms:
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Lung Neoplasms
Postoperative Complications
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists