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Completed

NCT Number: NCT00963573

Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of perennial allergic rhinitis.
  • Age >= 6 years old and <= 12 years old.
  • Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis.
  • Symptoms total score at admission >= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping).
  • Number of symptoms: At least three.

Exclusion criteria

  • Age < 6 years old or > 12 years old.
  • Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
  • Presence of systemic fungal infections.
  • Conscience or behavioral disturbances.
  • Current oral or parenteral steroid treatment.
  • Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine.
  • Known hypersensitivity to any of the study pharmacological combination components.

Treatment and study plan

Loratadine

Drug

loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Other names: SCH 029851

Betamethasone

Drug

loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Other names: SCH 029851

Primary outcomes

  1. To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children

    Time frame: Day 6 (Final visit)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Aug 21, 2009
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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