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
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
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
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
