The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Seoul National University

Status: Unknown

Conditions: Cough

Treatments: Drug: Rhinoebastel; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02065440

06-2011-65

Details and patient eligibility

About

To determine whether ebastine/pseudoephedrine is effective on subacute cough.

Full description

1. Visit 0 week

   • Patients with subacute cough,area randomized to either ebastine/pseudoephedrine or placebo for 1 week.
   • The cough severity and quality of life were measure with VAS score and cough-specific quality-of-life questionnaire(CQLQ)

2. Visit 1 week check VAS score and CQLQ

3. Visit 4 weeks check VAS score and CQLQ

Enrollment: 130 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with subacute cough(3-8 weeks)
• age: 20-70 years

Exclusion criteria

• Chest X-ray abnormality(+) as a probable cause of cough

• other explainable confirmed diagnosis(+) such as acute infectious disease

• Severe cough or cough complication which needs other anti-tussive agents.

• on ACEI

• with more than three hypertensive agents

• change of hypertension medication 3 months ago

• immunocompromized host

• relative or absolute contraindication for ebastine/pseudoephedrine

  1. hypersensitivity to ebastine/pseudoephedrine
  2. glaucoma
  3. moderate to severe hypertensive disease
  4. coronary heart disease
  5. hyperthyroidism
  6. moderate to severe liver disease
  7. benign prostate hyperplasia
  8. psychological problem
  9. Parkinson's disease
  10. on linezolid or supposed to use it.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

130 participants in 2 patient groups, including a placebo group

Ebastine/Pseudoephedrine

Active Comparator group

Description:

administration of ebastine/pseudoephedrine 1cap/day for 1 week.

Treatment:

Drug: Rhinoebastel

placebo

Placebo Comparator group

Description:

administration of placebo pill 1 cap/day for 1week

Treatment:

Drug: Placebo