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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010948
Receipt No. R000012768
Scientific Title Evaluation of the usefullness of perioperative administration of tiotropium and indacaterol in lung cancer patients with COPD.
Date of disclosure of the study information 2013/06/13
Last modified on 2016/01/14

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Basic information
Public title Evaluation of the usefullness of perioperative administration of tiotropium and indacaterol in lung cancer patients with COPD.
Acronym PALC study
Scientific Title Evaluation of the usefullness of perioperative administration of tiotropium and indacaterol in lung cancer patients with COPD.
Scientific Title:Acronym PALC study
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the usefulness of perioperative administration of inhaled Indacaterol plus inhaled Tiotropium in lung cancer patients with COPD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes forced expiratory volume in 1 second
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 18 microgram once daily Tiotropium
Interventions/Control_2 150 microgram once daily Indacaterol+
18 microgram once daily Tiotropium
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Non-small cell lung cancer stage1~3.
2) Partial lung resection or lobectomy.
3) Patients with the clinical diagnosis of COPD and with a FEV1/FVC of < 70% after inhalation of beta 2 agonist.
4) Patients with GOLD stage 1~3.
5) Patients aged >40 years old.
6) Patients that provided consent/permission
Key exclusion criteria 1) Patients with large atelectasis.
2) Patients with clear evidence of underlying bronchial asthma.
3) Patients that had airway infection or COPD exacerbation within the past 3 months after administration of the drug on trial.
4) Patients that cannot stop smoking at the start of the study.
5) Patients with a history of hypersensitivity to Tiotropium or Indacaterol.
6) Patients with benign prostatic hyperplasia.
7) Patients with glaucoma.
8) Pregnant or breast feeding patients.
9) Patients considered as ineligible by the panel of investigators.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Taguchi
Organization Mie University Graduate School of Medicine
Division name Dep. of Pulmonary and Critical Care Medicine
Zip code
Address 2-174,Edobashi,Tsu,Mie,514-8507,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsu Kobayashi
Organization Mie University Graduate School of Medicine
Division name Dep. of Pulmonary and Critical Care Medicine
Zip code
Address 2-174,Edobashi,Tsu,Mie,514-8507,Japan
TEL
Homepage URL
Email

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Mie University Graduate School of Medicine
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
2013 Year 06 Month 13 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 Terminated
Date of protocol fixation
2013 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 13 Day
Last modified on
2016 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012768

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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