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Status unknownNCT02504801Updated Jul 22, 2015

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

A Phase 4 interventional study of Budesonide in Post Operative Complication, Pulmonary, Lung Cancer and COPD, sponsored by Xiuyi Zhi. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-22.

Sponsored by Xiuyi Zhi · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post Operative Complication, Pulmonary
  • Lung Cancer
  • COPD

Keywords

  • primary lung cancer patients
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 73 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

This is the only study on the registry with Xiuyi Zhi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
73 participants (estimated)

Study arms

  • Active comparator
    nebulized Budesonide 2mg/4mL

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

    Drug: Budesonide

  • Placebo comparator
    nebulized saline 4mL

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

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.

06

What researchers measure

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

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02504801
Lead sponsor
Xiuyi Zhi
Responsible party
Xiuyi Zhi (Professor, Xuanwu Hospital, Beijing) — Sponsor-investigator
First posted
Jul 22, 2015
Start date
Jul 2015
Primary completion
Jul 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Jul 22, 2015

Study contacts

Xiuyi Zhi, Professor
Contact
hunthm1999@163.com
8613910086960

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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