UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Non-randomized controlled trial assessing the usefulness of new diagnostic and therapeutic algorithms for prolonged cough
Title of the study (Brief title)	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	Kiyoshi Sekiya
Organization	NHO Sagamihara National Hospital
Division name	Allergology
Address	Sakuradai 18-1, Minami-ku, Sagamihara-shi, Kanagawa, 252-0392, Japan
TEL	042-742-8311
Email	k-sekiya@sagamihara-hosp.gr.jp

Public contact
Name of contact person	Kiyoshi Sekiya
Organization	NHO Sagamihara National Hospital
Division name	Allergology
Address	Sakuradai 18-1, Minami-ku, Sagamihara-shi, Kanagawa, 252-0392, Japan
TEL	042-742-8311
Homepage URL
Email	k-sekiya@sagamihara-hosp.gr.jp

Sponsor
Institute	Sagamihara National Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036373