Open-label, single-center, randomized and parallel-group study to compare the efficacy of olopatadine hydrochloride and dextromethorphan hydrobromide in prolonged and chronic cough

UMIN ID: UMIN000001009

Registered date:01/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Prolonged and chronic cough
• Date of first enrollment: 2008/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

olopatadine hydrochloride 5mg b.i.d, for 2 weeks
dextromethorphan hydrobromide 15mg t.i.d, for 2 weeks

Outcome(s)

• Primary Outcome: Symptom scores and VAS score(at 0 and 2 weeks) Capsaicin cough sensitivity test(at 0 and 2weeks) Concentrations of substance P in sputum and plasma(at 0 and 2weeks)
• Secondary Outcome: 1. Pulmonary function tests(at 0 and 2weeks) 2. Inflammatory biomarkers of induced sputum and serum(at 0 and 2weeks) 3. Exhaled nitric oxide concentration(at 0 and 2weeks) 4. Parameters of impulse oscillometry(at 0 and 2weeks) 5. safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients with a history of hypersensitivity to olopatadine hydrochloride or dextromethorphan hydrobromide 2. Patients receiving monoamine oxidase inhibitor (MAOI) therapy and for 14 days after stopping MAOI therapy 3. Patients with a history of other chest disease 4. Patients taking angiotensin-converting enzyme inhibitors. 5. Patients during pregnancy or lactation 6. Inappropriate patients from the doctor's viewpoint

Related Information

• Primary Sponsor: Kyoto University Graduate School of Medicine
• Source(s) of Monetary Support: None