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A Combination of Intranasal Steroid/Oxymetazoline Leads to Faster Relief of Nasal Congestion Without Inducing Rhinitis Medicamentosa

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT00584987
First received: December 21, 2007
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.


Condition Intervention Phase
Allergic Rhinitis
 Drug: fluticasone furoate /oxymetazoline
Drug: Placebo
Drug: fluticasone furoate/placebo
Drug: Oxymetazoline/placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Combination of Intranasal Steroid/Oxymetazoline Leads to Faster Relief of Nasal Congestion Without Inducing Rhinitis Medicamentosa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • daily change in nasal congestion score [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean changes from baseline in RQLQ [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • mean changes from baseline in NPIF scores [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo/placebo nasal sprays
2 puffs of each nasal spray in each nostril in the pm
 Drug: Placebo
2 puffs of each nasal spray in each nostril in the pm
Active Comparator: fluticasone furoate/placebo
2 puffs of each nasal spray in each nostril in the pm
 Drug: fluticasone furoate/placebo
2 puffs of each nasal spray in each nostril in the pm
Active Comparator: Oxymetazoline/placebo
2 puffs of each nasal spray in each nostril in the pm
 Drug: Oxymetazoline/placebo
2 puffs of each nasal spray in each nostril in the pm
Active Comparator: fluticasone furoate /oxymetazoline
2 puffs of each nasal spray in each nostril in the pm
 Drug: fluticasone furoate /oxymetazoline
2 puffs of each nasal spray in each nostril in the pm

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females between 18 and 55 years of age.
  2. History of perennial allergic rhinitis.
  3. Positive skin test to dust mite, dog, cat or indoor mold antigen.
  4. And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry

Exclusion Criteria:

  1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  2. Pregnant or lactating women.
  3. Subjects treated with systemic steroids during the previous 30 days.
  4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
  5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
  6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
  7. Subjects treated with immunotherapy and are escalating their dose.
  8. Subjects on chronic anti-asthma medications.
  9. Subjects with polyps in the nose or a significantly displaced septum.
  10. Upper respiratory infection within 14 days of study start.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584987

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
GlaxoSmithKline
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

No publications provided

Responsible Party: Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00584987     History of Changes
Other Study ID Numbers: 15059B
Study First Received: December 21, 2007
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Oxymetazoline
Phenylephrine
Fluticasone
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013