A Study Comparing the Bioequivalence of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (Apotex, Inc.) to That of Dymista™ Nasal Spray (Meda Pharmaceuticals, Inc.) in the Treatment of Seasonal Allergic Rhinitis

Last updated: October 30, 2014
Sponsor: Apotex Inc.
Overall Status: Trial Status Unknown

Phase

2

Condition

Nasal Obstruction

Allergy

Rhinitis, Allergic, Perennial

Treatment

N/A

Clinical Study ID

NCT02279563
AZFL-NASU-05RB02-CE
  • Ages 18-65
  • All Genders

Study Summary

This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymista™ nasal spray.

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects who met all of the following criteria were eligible for inclusion in the study:

  1. Subjects who provided written informed consent.

  2. Subjects who were able to read and understand English.

  3. Males or females, 18 to 65 years old, inclusive.

  4. If the subject was a female of childbearing potential, she was not pregnant (confirmedby negative urine pregnancy test) or lactating. Females of childbearing potentialagreed to use reliable birth control measures throughout the study, defined asabstinence or use of an effective method of birth control (double barrier [femalesubject's partner using condom and female subject using diaphragm, contraceptivesponge, spermicide, or intrauterine device], or the use of a hormonal contraceptive [oral, patch, or inserted under the skin or injected into the muscle]). Femalesubjects who used oral contraceptives or levonorgestrel implants were required to havestarted the method at least 90 days prior to the screening visit. A female ofchildbearing potential was defined as a female who had experienced menarche, and whohad not undergone successful surgical sterilization (hysterectomy, bilateraloophorectomy or ovariectomy, bilateral tubal ligation or salpingectomy) or was notpost-menopausal for at least 1 year.

  5. At least a 2-year reliable medical history consistent with SAR, defined as symptomspresent during the previous two grass and/or pollen seasons.

  6. Positive skin test within 12 months of screening to at least one currently presentseasonal allergen in the geographical area that had a predictable allergen season (eg,birch pollen, ragweed, Mountain Cedar, etc) with a minimum skin test response of 3 mmor greater than a negative control, and a positive test to histamine, also defined asa response of 3 mm or greater than the negative control.

  7. Was capable of tolerating intranasal application of the study drug.

  8. No clinically significant results from the screening physical examination, nasalexamination, and medical history.

  9. Was willing and able to comply with the requirements of the protocol and was availablefor the full duration of the study, with no planned travel outside of the pollen areafor a substantial portion (>48 hours) of the study period.

  10. Was, in the Investigator's judgment (through exposure to allergen), expected torequire treatment throughout the entire study period.

Exclusion

Exclusion Criteria: Subjects who met any of the following criteria were excluded from the study:

  1. Signs or symptoms of nasal polyps, deviated septum, or any other condition (includingnasal piercing within the previous 3 months) which, in the opinion of theInvestigator, may have resulted in erroneous study data.

  2. Underwent nasal surgery or had nasal trauma within 3 months of Visit 1 (screening).

  3. Had active respiratory conditions that included, but were not limited to, acute orexacerbated chronic sinusitis, an abnormal sinus radiograph, an upper or lowerrespiratory tract infection, or rhinitis medicamentosa.

  4. Had PAR that required or was expected to require active PAR treatment during the studyperiod.

  5. Had a respiratory tract infection (including otitis media and streptococcus) thatrequired antibiotic treatment within 2 weeks of Visit 1 (screening).

  6. Used any of the prohibited medications prior to the start of the single-blind, placebolead-in visit (Visit 2) within the time period specified in the protocol

Study Design

Total Participants: 595
Study Start date:
December 01, 2013
Estimated Completion Date: