UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000367 |
|---|---|
| Receipt number | 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 20:31:46 |
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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
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
Sponsor or person
Institute
Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000458
