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

NCT02238210 | Completed Phase 4

• 1 other identifier: 244.2503
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cold

Outcome Measures

Primary Outcomes (3)

• Patient's parent/legal guardian global assessment - common cold group

  Day 4

• Number of patients with adverse events

  up to 21 days

• Patient's parent/legal guardian global assessment - allergy group

  Day 14

Secondary Outcomes (8)

• Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group

  Day 4

• Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group

  Day 4

• Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group

  Day 4

• 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 rhinorrhea (runny nose) rated on 5-point scale - allergy group

  Day 14

Study Arms (2)

Atrovent® - common cold group

EXPERIMENTAL

Treatment duration for common cold group - three time daily for 4 days

Drug: Atrovent®

Experimental: Atrovent® - allergy group

EXPERIMENTAL

Treatment duration for allergy group - three time daily for 14 days

Drug: Atrovent®

Interventions

Atrovent® DRUG

Atrovent® - common cold group; Experimental: Atrovent® - allergy group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female at least 2 but not older than 5 years of age at screening
• Have a diagnosis of a common cold defined as presence of acute onset of rhinorrhea (within 48 hours of screening visit) and at least 1 of the following:
• Presence of swollen nasal membranes characteristic of a common cold on examination at screening
• Presence of fever up to 102°F (oral or equivalent) within 48 hours of visit (may be taken at home/away from the clinic) or at time of screening
• Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire
• Male or female at least 2 but not older than 5 year of age
• Have a diagnosis of seasonal or perennial allergic rhinitis defined as having both of the following:
• Positive skin or Radioallergosorbent test (RAST) test to a relevant allergen within 12 months of screening or at the screening visit. For the purpose of this trial a positive skin test is defined as wheal diameter that is at least 3 mm greater than the negative control
• Positive prior history for atopy with nasal symptoms associated with expose to allergens
• Symptoms associated with rhinorrhea for at least 48 hours prior to the screening visit
• Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire

You may not qualify if:

• Significant cardiovascular, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease. A significant disease was defined as one which, in the opinion of the Investigator, either put the patient at risk because of participation in the trial or influenced the results of the trial or the patient's ability to participate in the trial
• Presence of rales or rhonchi suggestive of a lower respiratory tract infection
• An oral (or equivalent) temperature higher than 102°F
• Presence of otitis media
• Be initiating or advancing immunotherapy regimen during the course of this trial. Patients receiving a maintenance dose of immunotherapy are eligible
• Known intolerance to anticholinergics of hypersensitivity to benzalkonium chloride
• Excluded medications prior to Visit 1 and during the trial included:
• hours before
• Over-the-counter decongestants or nasal/ocular cromolyn
• days before:
• Anticholinergics
• Over-the-counter antihistamines
• sympathomimetic decongestants
• days before:
• Fexofenadine

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Common Cold

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 12, 2014
• Study Start: December 1, 2002
• Primary Completion: May 1, 2003
• Last Updated: September 12, 2014

Record last verified: 2014-09