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Non-randomized controlled trial assessing the usefulness of new diagnostic and therapeutic algorithms for prolonged cough

Non-randomized controlled trial assessing the usefulness of new diagnostic and therapeutic algorithms for prolonged cough - NHOM-Cough

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031854
Enrollment
500
Registered
2018-03-23
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Interventions

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 sta

Sponsors

Sagamihara National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
1) Frequency of cases judged to have improved cough 2) Clinical diagnosis on the cause of cough 3) Adverse events

Countries

Japan

Contacts

Public ContactKiyoshi Sekiya

NHO Sagamihara National Hospital Allergology

k-sekiya@sagamihara-hosp.gr.jp042-742-8311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026