Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy

Phase 4

Completed

• Conditions: Cold
• Interventions: Drug: Atrovent®

• Registration Number: NCT02238210
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5 years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from symptoms of rhinorrhea associated with allergies

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-05
• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Last Update Submitted: 2014-09-11
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Atrovent® - allergy group	Atrovent®	Treatment duration for allergy group - three time daily for 14 days
Atrovent® - common cold group	Atrovent®	Treatment duration for common cold group - three time daily for 4 days

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 21 days
Patient's parent/legal guardian global assessment - allergy group	Day 14
Patient's parent/legal guardian global assessment - common cold group	Day 4

Secondary Outcome Measures

Name	Time	Method
Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group	Day 14	daily assessment by e-diary
Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group	Day 4	daily assessment by e-diary
Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group	Day 4	daily assessment by e-diary
Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group	Day 14	daily assessment by e-diary
Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group	Day 4	daily assessment by e-diary
Number of patients with clinically findings in nasal and otoscopic examination - common cold group	up to day 4
Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group	Day 14	daily assessment by e-diary
Number of patients with clinically findings in nasal and otoscopic examination - allergy group	up to day 14