UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031854 |
|---|---|
| Receipt number | R000036373 |
| Scientific Title | Non-randomized controlled trial assessing the usefulness of new diagnostic and therapeutic algorithms for prolonged cough |
| Date of disclosure of the study information | 2018/03/23 |
| Last modified on | 2018/03/30 08:55:18 |
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Basic information
Public title
Non-randomized controlled trial assessing the usefulness of new diagnostic and therapeutic algorithms for prolonged cough
Acronym
NHOM-Cough
Scientific Title
Non-randomized controlled trial assessing the usefulness of new diagnostic and therapeutic algorithms for prolonged cough
Scientific Title:Acronym
NHOM-Cough
Region
| Japan |
Condition
Condition
Cough
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify contribution of an algorithm to earlier cough improvement by defining the procedures for diagnosing the cause of prolonged cough as a novel diagnosis/treatment algorithm after defining the treatment sequence and conducting a therapeutic diagnosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of days required to be judged as cough improved since first visit (improvement of VAS 60% or more maintained for more than 3 days)
Key secondary outcomes
1) Frequency of cases judged to have improved cough
2) Clinical diagnosis on the cause of cough
3) Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Registered cases for 1 year from the start of the study will be allocated to the control group in which we perform diagnosis and treatment based on the guidelines. Treatment in two or more disease states cannot be performed. Also, the use of antitussive agent which is symptomatic treatment is not allowed.
Interventions/Control_2
After an interval of 5 months from the end of registration of the control group, registered cases for 1 year will be allocated to the intervention group in which we perform a therapeutic diagnosis according to the prescribed diagnostic and treatment algorithm.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Aged 20 to 75 at the time of case registration
(2) First-visit patients whose main complaint is cough (currently not in hospital with other respiratory diseases in the department)
(3) Patients with cough lasting more than 3 weeks accompanying little sputum
(4) Whose VAS of the cough in the last week at the visit is 5 cm or more
(5) Provided informed consent to various examinations, medical questionnaires, cough diary entries of up to 10 weeks after the start of control/intervention period, drug restrictions related to diagnostic treatment and antitussive agent, and provided written consent for participation in this study
Key exclusion criteria
(1) Confirmed obvious cough improvement naturally or by treatment during the course before visit
(2) Having a history of treatment as asthma including cough asthma within three years besides this episode
(3) Having a history or complications of chronic respiratory/heart/kidney disease, GERD, autoimmune /inflammatory bowel disease, tonsil hypertrophy, or laryngeal disease
(4) Pregnant or possibly pregnant
(5) Having a history of drug irritation or severe side effects to macrolide antibiotics, PPI, ICS, H1 blocker, H2 blocker, or beta stimulant
(6) Confirmed pulmonary shadow abnormality or obvious heart expansion in chest X-ray
(7) With obvious airway infection symptoms (fever of 37.5 degree Celsius. or higher or purulent sputum) at the initial visit to the institution
(8) Whose Brinkman Index (average number of smokers per day x total smoking years) is 400 or more
(9) With the rale sound by consultation including mild rales and forced expiration. (To listen carefully to mild twisting sounds in the lower lungs and auscultation with mild wheezing
(10) Using ACE inhibitors (but can enter at 2 weeks or later after discontinuation)
(11) Taking orally H2 blockers, PPI, oral steroids, systemic immunosuppressants or psychotropic drugs for some underlying disease
(12) Others where the attending doctor judged inappropriate to participate in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Sekiya |
Organization
NHO Sagamihara National Hospital
Division name
Allergology
Zip code
Address
Sakuradai 18-1, Minami-ku, Sagamihara-shi, Kanagawa, 252-0392, Japan
TEL
042-742-8311
k-sekiya@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Sekiya |
Organization
NHO Sagamihara National Hospital
Division name
Allergology
Zip code
Address
Sakuradai 18-1, Minami-ku, Sagamihara-shi, Kanagawa, 252-0392, Japan
TEL
042-742-8311
Homepage URL
k-sekiya@sagamihara-hosp.gr.jp
Sponsor or person
Institute
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
相模原病院(神奈川県)、東京病院(東京都)、名古屋医療センター(愛知県)、金沢医療センター(石川県)、南岡山医療センター(岡山県)、福岡病院(福岡県)、沖縄病院(沖縄県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036373
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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