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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014361
Receipt No. R000016701
Scientific Title Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Date of disclosure of the study information 2014/06/25
Last modified on 2020/12/28

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Basic information
Public title Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Acronym Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Scientific Title Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Scientific Title:Acronym Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Region
Japan

Condition
Condition Primary lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will investigate the effect of Salmeterol on surgery for primary lung cancer in COPD patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Improvement of pulmonary function associated with inhalation of Salmeterol
Key secondary outcomes 1) Rate of postoperative complications
2) Self-assessment of respiratory insufficiency
3) 1-year overall survival
4) Rate of adverse events
5) Evaluation of postoperative compliance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Inhalation of Salmeterol, 50 microgram twice daily, starting from 10 days before the surgery.
Interventions/Control_2 No inhalation of Salmeterol.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Clinically suspected or diagnosed primary lung cancer.
2)FEV1.0/FVC < 0.70, assessed by spirometry.
3)Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria I-III.
4)Modified Medical Research Council (MRC) score =<1.
5)Resectable cancer lesion by single lobectomy.
6)No previous treatment of COPD or asthma.
7)No past history of pulmonary resection.
8)Patients being able to stop smoking at the time of the registry to this trial.
9)Adequate organ function tolerable for the general anesthesia.
10)Capable for inhalation.
11)Age of 20 years or older.
12)ECOG performance status: 0, 1
13)Written informed consent to participate.
Key exclusion criteria 1)Median sternotomy.
2)Combined resection of the chest wall.
3)Active infection.
4)Active double cancer.
5)Current or previous history of severe heart diseases or cerebrovascular disases. Uncontrolled diabetes mellitus or hypertension. Interstitial pneumonia. Arrhythmia requiring antiarrhythmic continuously. Renal dysfunction necessitating blood purification therapy.
6)Patients with psychiatric disease.
7)Patients requiring systemic steroids medication.
8)Pregnant and lactating female, female who has possibility of pregnancy.
9)Past history of drug allergy.
10)Hypokalemia.
11)Patients who were judged inappropriate to enter this trial by physician.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taichiro Goto
Organization Yamanashi Prefectural Central Hospital
Division name General Thoracic Surgery
Zip code
Address 1-1-1 Fujimi, Kofu-shi, Yamanashi 400-8506, Japan
TEL 055-253-7111
Email taichiro@1997.jukuin.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taichiro Goto
Organization Yamanashi Prefectural Central Hospital
Division name General Thoracic Surgery
Zip code
Address 1-1-1 Fujimi, Kofu-shi, Yamanashi 400-8506, Japan
TEL 055-253-7111
Homepage URL
Email taichiro@1997.jukuin.keio.ac.jp

Sponsor
Institute Yamanashi Prefectural Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2014 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 24 Day
Last modified on
2020 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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