UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006950 |
|---|---|
| Receipt number | R000008077 |
| Scientific Title | Effects of additional inhaled tiotropium in relapsing polychondritis with airway involvement |
| Date of disclosure of the study information | 2011/12/26 |
| Last modified on | 2014/06/01 14:01:25 |
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Basic information
Public title
Effects of additional inhaled tiotropium in relapsing polychondritis with airway involvement
Acronym
Inhaled Tiotropium in RP
Scientific Title
Effects of additional inhaled tiotropium in relapsing polychondritis with airway involvement
Scientific Title:Acronym
Inhaled Tiotropium in RP
Region
| Japan |
Condition
Condition
Relapsing polychondritis
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects and safety of tiotropium in relapsing polychndritis with airway involvement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Dyspnea score (MMRC, Borg scale, visual analog score)
2. Change in FEV1
3. Airway diameter and dimension using MDCT
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
To record subjective symptoms, pulmonary function, airway diameter and dimension 3 months before, at baseline and 3 months following tiotropium
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Fulfill the McAdam or Damiani and Levine diagnosis criteria. To clarify airway chondritis using biopsy, MRI or ultrasonography
2) Airway involvement confirmed by CT
3) Respiratory symptom
4) Stable treatment for 4 weeks.
Key exclusion criteria
1) Glaucoma or benign prostatic hypertrophy
2) Use of other anticholinergic agents within 1 month
3) Refused informed consent
4) Pregnant, possibly pregnant, or lactating patients.
5) Severe lung cancer, COPD and pneumonia except for bronchial asthma patients.
6) Patients judged inappropriate by the doctor in charge.
7) Current smokers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruomi Miyazawa |
Organization
St. Marianna University School of Medicine
Division name
Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Handa |
Organization
St. Marianna University School of Medicine
Division name
Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of 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
| 2011 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We experienced that inhaled tiotropium showed a marked improvement in airway involvement for one patient. However, no significant effects were noted in 8 RP patients for dyspnea (MMRC), visual analog score (VAS) or pulmonary function tests (spirometry and impulse oscillometry), before and after inhaled tiotropium.
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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 26 | Day |
Last modified on
| 2014 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008077
