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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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