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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Cold

Treatments

Drug: Atrovent®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02238210

244.2503

Details and patient eligibility

About

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

Enrollment

230 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for patients with common cold

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

Inclusion Criteria for patients with allergies

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

General Exclusion Criteria for both common cold and allergy

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:
1. 24 hours before
  - Over-the-counter decongestants or nasal/ocular cromolyn
2. 3 days before:
  - Anticholinergics
  - Over-the-counter antihistamines
  - sympathomimetic decongestants
3. 5 days before:
  - Fexofenadine
  - Loratadine
4. 7 days before:
  - Cetirizine
  - antihistamines such as Atarax® or doxepin hydrochloride
  - Antidepressants
5. 14 days before:
  - Intranasal steroids
6. 28 days before:
  - Steroids (oral and injectable)
  - Leukotriene modifiers (e.g. Accolate®, Singulair®)
  - Other investigational drugs
Participation in any trial with an investigational drug within 30 days of the screening visit
Nasal obstruction greater than 50% that would prevent deposition of trial drug
The parent/legal guardian has a disability or lives in a geographical location that could impair compliance with the protocol or visits to the trial center

Exclusion criteria for patients with a common cold

History or perennial allergic rhinitis or seasonal allergic rhinitis (SAR) with allergen in season
Positive Streptococcus test

Exclusion criteria for patients with allergies

Patients with active infectious rhinitis (common cold) as determined by history and physical
Patients with upper or lower respiratory infection at screening