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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000367
Receipt No. R000000458
Scientific Title Multicentric study of combination therapy of theophylline and tiotropium in COPD
Date of disclosure of the study information 2006/04/01
Last modified on 2008/12/08

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Basic information
Public title Multicentric study of combination therapy of theophylline and tiotropium in COPD
Acronym Theophylline and tiotropium in COPD
Scientific Title Multicentric study of combination therapy of theophylline and tiotropium in COPD
Scientific Title:Acronym Theophylline and tiotropium in COPD
Region
Japan

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

Objectives
Narrative objectives1 To study the efficacy of combination therapy of theophylline and tiotropium
for COPD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lung function test
QOL (St George Respiratory Questionnaire)
Key secondary outcomes Blood concentration of theophylline
Induced sputum

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After 4 weeks of administration of tiotropium, both oral theophylline(200-800mg/day) and tiotropium will be administerd for 4 weeks.
Interventions/Control_2
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria COPD patient with a persistant symptoms(chronic cough, sputum, dyspnea),
45 years old or older,
Post bronchodilator FEV1/FVC<70%, Smoking history 10 pack-years or more
Patients who have signed the agreement for participation in this study
Key exclusion criteria Patients for whom theophylline or tiotropium is contraindicated
Patients who have used other long acting bronchodilator, other xanthine, and inhaled corticosteroid within 1 month
Patients with asthma
Patients who need persistant oxygen therapy
Patients with respiratory infection within 1 month
Patients with severe hepatic, renal, heart, hematologic abnormality
Patients with active tuberculosis or pulmonary sequelae of tuberculosis
Patients with cancer within 2 years.
(excluding basal cell carcinoma)
Patients with cystic fibrosis and bronchiectasis
Patients who are or could be pregnant
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Yokoyama
Organization Graduate school of biomedical sciences, Hiroshima university
Division name Department of molecular and internal medicine
Zip code
Address 1-2-3 Kasumi Minami-ku Hirosima city 734-8551 Japan
TEL 082-257-5196
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Haruta
Organization Graduate school of biomedical sciences, Hiroshima university
Division name Department of molecular and internal medicine
Zip code
Address 1-2-3 Kasumi Minami-ku Hirosima city 734-8551 Japan
TEL 082-257-5196
Homepage URL
Email

Sponsor
Institute Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal medicine
Institute
Department

Funding Source
Organization Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal 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
2006 Year 04 Month 01 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
2005 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 24 Day
Last modified on
2008 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000458

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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