Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00637611
First received: March 10, 2008
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Fexofenadine HCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.

Enrollment: 1010
Study Start Date: February 2003
Study Completion Date: April 2003
Intervention Details:
    Drug: Fexofenadine HCl
    Other Name: Allegra
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, 15 years of age or older
  • History of seasonal allergic rhinitis (SAR) during the fall pollen season, for at least the previous 2 years
  • History of having a positive response to antihistamines for symptoms of SAR
  • Must be skin test positive to ragweed within the last 15 months with at least a moderate reaction as defined by a wheal 7 mm greater than the diluent wheal after intradermal skin test or a wheal 5 mm greater than the diluent wheal after skin prick test. A skin test performed in the previous 15 months may be used to qualify the patient if it was performed at the investigator's site and recorded in the subject's medical record
  • All females must have negative urine pregnancy test at screening visit
  • Willing and able to adhere to visit schedules and all study requirements

Exclusion Criteria:

  • Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
  • Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
  • Pregnancy or breast-feeding
  • History of hypersensitivity to the study medications or to drugs with similar chemical structures
  • Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  • Upper or lower respiratory infection within 14 days of the first priming visit
  • Diagnosis of sinusitis within 30 days of the first priming visit
  • Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
  • Treatment with any investigational drug in the last 30 days before study entry
  • Recent history of drug or alcohol abuse
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Unlikelihood to comply with protocol such as those with uncooperative attitude or the inability to return for follow-up visits or to complete the study
  • Subjects who were randomized into this trial will not be eligible to participate in another fexofenadine hydrochloride 180 mg vs montelukast sodium 10 mg onset of action study (planned to be conducted in 2003)
  • Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637611

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637611     History of Changes
Other Study ID Numbers: M016455A_4149
Study First Received: March 10, 2008
Last Updated: January 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Fexofenadine
Montelukast
Terfenadine
Anti-Allergic Agents
Anti-Asthmatic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014