NIPH Clinical Trials Search

Persistent cough in asthma patients study

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Asthma
Date of first enrollment	15/05/2026
Target sample size	500
Countries of recruitment
Study type	Observational
Intervention(s)	None

Outcome(s)

Primary Outcome

1. To determine the proportion of patients with persistent cough in a population of patients with asthma who have been receiving maintenance asthma treatment (ICSs/LABAs/LAMAs) for at least 4 consecutive weeks in a real-world Japanese clinical setting. 2. To determine the disease burden and lived experience of persistent cough in patients with asthma who have been receiving maintenance asthma treatment using qualitative interviews.

Secondary Outcome

To describe Asthma control test (ACT), Cough Severity-Visual Analog Scale (CS-VAS), cough-specific QoL (LCQ), sleep quality (PSQI), work productivity activity impairment (WPAI), effect of urinary incontinence (ICIQ-SF), and the profile of rhinitis symptoms (HARQ).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. A diagnosis of asthma is recorded in the DigiKar EMR data. 2. Male or female sex and aged 18 years or older (assessed using the DigiKar EMR data). 3. Prescription records for ICS/LABA/LAMA are available in DigiKar EMR data for at least 4 consecutive weeks immediately preceding the data extraction. 4. Electronic signed and dated informed consent is provided. 5. The patient is willing and able to complete the web-based survey. 6. Scores on the Morisky Medication Adherence Scale-8 (MMAS-8) are >-6; this instrument will be administered as part of the web survey.
Exclude criteria	1. Current smoker or former smoker with a total lifetime smoking history of 10 years or more at the time of the web-based survey (assessed by self-reporting in the survey). 2. A confirmed diagnosis in DigiKar EMR data of another chronic respiratory disease known to be a primary cause of cough within 12 months before distribution of the web-based survey. 3. Presence of prescription records in DigiKar EMR data for six or more short-acting B2-agonist (SABA) inhalers within 12 months before distribution of the web-based survey. 4. Presence of a prescription record in DigiKar EMR data for an angiotensin-converting enzyme (ACE) inhibitor within 12 months before distribution of the web-based survey. 5. Presence of a prescription record in DigiKar EMR data for an asthma-related biological therapy within 12 weeks before distribution of the web-based survey. 6. Current participation in any interventional clinical study within 12 months before the web-based survey (assessed by self-reporting in the web-based survey).