A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Apotex Inc.
ClinicalTrials.gov Identifier:
NCT00987233
First received: September 29, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

A randomized, double-blind, placebo-controlled parallel-group study, comparing the bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of seasonal allergic rhinitis.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: triamcinolone acetonide aqueous nasal spray (Apotex Inc.)
Drug: triamcinolone acetonide aqueous nasal spray (Nasacort® AQ)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Apotex Inc.:

Primary Outcome Measures:
  • To demonstrate similar efficacy (bioequivalence) of the generic triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) with that of the marketed reference drug, Nasacort® AQ Nasal Spray in the treatment of seasonal allergic rhinitis.

Arms Assigned Interventions
Experimental: triamcinolone acetonide aqueous nasal spray Drug: triamcinolone acetonide aqueous nasal spray (Apotex Inc.)
It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
Active Comparator: Nasacort® AQ Nasal Spray Drug: triamcinolone acetonide aqueous nasal spray (Nasacort® AQ)
It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.
Placebo Comparator: Placebo Drug: Placebo
It is to be self-administered; the dosing regimen will be 2 sprays (actuations) into each nostril, once daily. This is the dosing regimen during placebo lead-in and randomized treatment phases. Each actuation of active treatment is equivalent to 55 ug of triamcinolone acetonide, for a total daily dose of 220ug triamcinolone acetonide per day.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understands the requirements of the study and provides written informed consent;
  • Is a male or female between 18 and 65 years of age;
  • At least a 2-year history of seasonal allergic rhinitis;
  • The presence of IgE-mediated hypersensitivity to local pollen confirmed by a positive response to either skin prick or intradermal testing within the past 12 months. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test;
  • In order to enter the placebo lead-in period, the subject must have a score of at least 6 on a 24-hour reflective TNSS completed during Visit 2;
  • Is in general good health as determined by screening evaluations and the judgment of the Investigator;
  • If female of childbearing potential, is not pregnant (confirmed by negative urine pregnancy test), non-lactating, and will use reliable birth control measures throughout the study. Female of child bearing potential is defined as a female who has experienced menarche, and who has not undergone successful surgical sterilization: hysterectomy, bilateral oophorectomy or ovariectomy, bilateral tubal ligation or salpingectomy; or is not postmenopausal for at least 1 year.;
  • If receiving immunotherapy, must be on a stable maintenance regimen for at least 30 days before Visit 1, and should maintain the same dose throughout the study (Low dose antibiotic therapy given prophylactically and started prior to Day -7 is acceptable.);
  • Has not used systemic steroids or topical steroids (inhaled, intranasal, or intraocular) within 30 days before Visit 2; Is capable of tolerating intranasal application of the study drug; and
  • Is willing and able to comply with the requirements of the protocol and intends to complete the study.

Exclusion Criteria:

  • Evidence of any unstable or clinically significant, hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, or autoimmune disorder/condition/disease that in the opinion of the Investigator could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives;
  • Presence or history of ocular herpes simplex, cataracts, or glaucoma;
  • Inability to avoid exposure to chickenpox or measles;
  • Respiratory tract infection within two weeks prior to screening;
  • Infection requiring oral antibiotic treatment two weeks prior to screening;
  • Significant pulmonary disease and/or active asthma requiring daily medication;
  • Signs or symptoms of nasal polyps, deviated septum, or any other condition, which in the opinion of the Investigator, may result in erroneous study data; Known intolerance (hypersensitivity or serious adverse reaction) to corticosteroids;
  • History within the last 5 years or current evidence of alcohol or drug abuse;
  • Current use of therapies or medications (e.g., tricyclic antidepressants and others. See Section 8.1, Prohibited Medications) that would affect assessment of the effectiveness of the study drugs;
  • Unable to withhold any prohibited medication (see Section 8.1, Prohibited Medications);
  • Use of any of the following prior to the start of the single-blind placebo lead-in visit (Visit 2) within the time periods specified:

Time prior to Visit 2

  • Intranasal or systemic corticosteroids 30 days
  • Ocular corticosteroids 30 days
  • Intranasal cromolyn 14 days
  • Leukotriene inhibitors 14 days
  • Loratadine10 days
  • Intranasal or systemic antihistamines (including sleep and diet aids and cold preparations) 3 days
  • Has received any investigational drug or participated in an investigational research study within 30 days of entering this study;
  • Documented evidence of acute or significant chronic sinusitis, as determined by the investigator;
  • Rhinitis medicamentosa;
  • Planned travel outside the study area for a substantial portion of the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987233

Locations
United States, New Jersey
Clinsys Clinical Research, Inc.
Bedminster, New Jersey, United States, 07921
Sponsors and Collaborators
Apotex Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00987233     History of Changes
Other Study ID Numbers: TRIA-NASO-05RB02-CE
Study First Received: September 29, 2009
Last Updated: September 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014