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The Effect of Ebastine/Pseudoephedrine on Subacute Cough

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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