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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000006950 |
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Date of registration:
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26/12/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of additional inhaled tiotropium in relapsing polychondritis with airway involvement
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Scientific title:
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Effects of additional inhaled tiotropium in relapsing polychondritis with airway involvement - Inhaled Tiotropium in RP |
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Date of first enrolment:
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2011/12/01 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008077 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Teruomi Miyazawa |
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Address:
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2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
Japan |
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Telephone:
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044-977-8111 |
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Email:
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Affiliation:
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St. Marianna University School of Medicine Respiratory and Infectious Diseases, Department of Internal Medicine |
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Name:
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Hiroshi Handa |
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Address:
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2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
Japan |
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Telephone:
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044-977-8111 |
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Email:
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Affiliation:
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St. Marianna University School of Medicine Respiratory and Infectious Diseases, Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Relapsing polychondritis
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Intervention(s)
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To record subjective symptoms, pulmonary function, airway diameter and dimension 3 months before, at baseline and 3 months following tiotropium
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Primary Outcome(s)
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1. Dyspnea score (MMRC, Borg scale, visual analog score) 2. Change in FEV1 3. Airway diameter and dimension using MDCT
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Source(s) of Monetary Support
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St. Marianna University School of Medicine Division of Respiratory and Infectious Diseases, Department of Internal Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/06/2014 |
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URL:
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