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Trial record 9 of 151 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02238210
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 11, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE December 2002
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
  • Patient's parent/legal guardian global assessment - common cold group [ Time Frame: Day 4 ]
  • Number of patients with adverse events [ Time Frame: up to 21 days ]
  • Patient's parent/legal guardian global assessment - allergy group [ Time Frame: Day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
  • Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group [ Time Frame: Day 4 ]
    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 [ Time Frame: Day 4 ]
    daily assessment by e-diary
  • Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group [ Time Frame: Day 4 ]
    daily assessment by e-diary
  • Number of patients with clinically findings in nasal and otoscopic examination - common cold group [ Time Frame: up to day 4 ]
  • Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group [ Time Frame: Day 14 ]
    daily assessment by e-diary
  • Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group [ Time Frame: Day 14 ]
    daily assessment by e-diary
  • Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group [ Time Frame: Day 14 ]
    daily assessment by e-diary
  • Number of patients with clinically findings in nasal and otoscopic examination - allergy group [ Time Frame: up to day 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy
Official Title  ICMJE A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) With Rhinorrhea Associated With a Common Cold or Allergy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cold
Intervention  ICMJE Drug: Atrovent®
Study Arms  ICMJE
  • Experimental: Atrovent® - common cold group
    Treatment duration for common cold group - three time daily for 4 days
    Intervention: Drug: Atrovent®
  • Experimental: Experimental: Atrovent® - allergy group
    Treatment duration for allergy group - three time daily for 14 days
    Intervention: Drug: Atrovent®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2014)
230
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02238210
Other Study ID Numbers  ICMJE 244.2503
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP