Post Operative Complication, PulmonaryPhase 4NCT02504801
Efficacy of Nebulized Pulmicort Respules in Primary Lung Cancer Patients With COPD
A Phase 4 study testing Budesonide in people with Post Operative Complication, Pulmonary and Lung Cancer, run by Xiuyi Zhi.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Post Operative Complication, Pulmonary, Lung Cancer, COPD
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD
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
- Being tested
- Budesonide
- Keywords
- primary lung cancer patients
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
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 group | Role | What they receive |
|---|---|---|
| nebulized Budesonide 2mg/4mL | Active comparator | +terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID Receives: Drug: Budesonide |
| nebulized saline 4mL | Placebo comparator | +terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Complication, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuyi Zhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiuyi Zhi, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504801
- Sponsor's protocol ID
- ISSPULR0007
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD
- ClinicalTrials.gov ID
- NCT02504801
- Acronym / sponsor ID
- ISSPULR0007
- Conditions
- Post Operative Complication, Pulmonary, Lung Cancer, COPD
- Keywords
- primary lung cancer patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Xiuyi ZhiUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nebulized Budesonide 2mg/4mL | Active comparator | Drug: Budesonide+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID |
| nebulized saline 4mL | Placebo comparator | –+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudesonideTo 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. | Drug | nebulized Budesonide 2mg/4mL |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide in people with Post Operative Complication, Pulmonary and Lung Cancer, run by Xiuyi Zhi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuyi Zhi, Professor (8613910086960, hunthm1999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.