UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010948
Receipt number 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 15:42:38

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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 or person

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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