UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005139 |
|---|---|
| Receipt number | R000006098 |
| Scientific Title | Effect of Tiotropium on sputum and cough in COPD patients with prolonged sputum |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2011/02/24 09:59:27 |
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Basic information
Public title
Effect of Tiotropium on sputum and cough in COPD patients with prolonged sputum
Acronym
Effect of Tiotropium on sputum and cough in COPD patients with prolonged sputum
Scientific Title
Effect of Tiotropium on sputum and cough in COPD patients with prolonged sputum
Scientific Title:Acronym
Effect of Tiotropium on sputum and cough in COPD patients with prolonged sputum
Region
| Japan |
Condition
Condition
Outpatients of Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 8-week treatment with inhaled tiotropium bromide via Respimat on the sputum using CASA-Q in COPD patients with prolonged sputum.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy evaluation:
Cough and Sputum Assessment Questionnaire (CASA-Q).
Key secondary outcomes
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
Spiriva Respimat as a marketed product
dose: 5mcg once daily in the morning
duration of treatment 8weeks
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients of either sex, 40 years or older,
2) Diagnosis of COPD, having prolonged sputum.
3) Cigarette smoking history of ≥ 20 pack-years
4) FEV1 < = 80% of predicted normal
Predicted normal values will be calculated as follows:
Males: FEV1.0 predicted (L) = 0.036 x (height (cm)) – 0.028 x age (years) – 1.178
Females: FEV1.0 predicted (L) = 0.022 x (height (cm)) – 0.022 x age (years) – 0.005
5) FEV1 ≤ 70% of FVC
6) Patients who had been continuously expectorating more than 30 g of sputum/day for at least two weeks
7) Patients who were judged to be eligible for enrollment by the investigator
8) Written Informed Consent Form
Key exclusion criteria
1) Patients whose dose of antibiotics, steroid, 2 stimulant, anti-cholinergic agent, theophylline preparation or expectorant was changed within 1 month before the screening test.
2) Patients who began treatment with an ACE inhibitor or whose dose of ACE inhibitor was changed within 1 month before the screening test.
3) Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test).
4) Patients with a history of hypersensitivity to the components of Tiotropium Respimat
5) Patients with contraindication of Tiotropium Respimat.
6) Other than the above, patients judged by the investigator to be inappropriate as the subjects of study.
7) Patients with alcohol or drug abuse.
8) Patients who are unable to utilize spirometry
9) Patients who were judged not to be eligible for enrollment by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nagai |
Organization
Tokyo Women's Medical University
Division name
First Department of Medicine
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Tamaoki |
Organization
Tokyo Women's Medical University
Division name
First Department of Medicine
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
+81-3-3353-8111
Homepage URL
jtamaoki@chi.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2011 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 25 | Day |
Last modified on
| 2011 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006098
