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

Apotex

Status and phase: Unknown; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray; Drug: Placebo; Drug: Dymista™ Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02279563

AZFL-NASU-05RB02-CE

Details and patient eligibility

About

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.

Enrollment: 595 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 (confirmed by negative urine pregnancy test) or lactating. Females of childbearing potential agreed to use reliable birth control measures throughout the study, defined as abstinence or use of an effective method of birth control (double barrier [female subject's partner using condom and female subject using diaphragm, contraceptive sponge, spermicide, or intrauterine device], or the use of a hormonal contraceptive [oral, patch, or inserted under the skin or injected into the muscle]). Female subjects who used oral contraceptives or levonorgestrel implants were required to have started the method at least 90 days prior to the screening visit. A female of childbearing potential was defined as a female who had experienced menarche, and who had not undergone successful surgical sterilization (hysterectomy, bilateral oophorectomy or ovariectomy, bilateral tubal ligation or salpingectomy) or was not post-menopausal for at least 1 year.
5. At least a 2-year reliable medical history consistent with SAR, defined as symptoms present during the previous two grass and/or pollen seasons.
6. Positive skin test within 12 months of screening to at least one currently present seasonal 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 mm or greater than a negative control, and a positive test to histamine, also defined as a 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, nasal examination, and medical history.
9. Was willing and able to comply with the requirements of the protocol and was available for the full duration of the study, with no planned travel outside of the pollen area for a substantial portion (>48 hours) of the study period.
10. Was, in the Investigator's judgment (through exposure to allergen), expected to require treatment throughout the entire study period.

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 (including nasal piercing within the previous 3 months) which, in the opinion of the Investigator, 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 or exacerbated chronic sinusitis, an abnormal sinus radiograph, an upper or lower respiratory tract infection, or rhinitis medicamentosa.
4. Had PAR that required or was expected to require active PAR treatment during the study period.
5. Had a respiratory tract infection (including otitis media and streptococcus) that required antibiotic treatment within 2 weeks of Visit 1 (screening).
6. Used any of the prohibited medications prior to the start of the single-blind, placebo lead-in visit (Visit 2) within the time period specified in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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595 participants in 3 patient groups, including a placebo group

Azelastine HCl and Fluticasone Propionate Nasal Spray

Experimental group

Description:

The investigational product was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number KL1981, Expiry Date Mar 2015.

Treatment:

Drug: Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray

Dymista™ Nasal Spray

Active Comparator group

Description:

The reference product was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number G30349, Expiry Date Mar 2015.

Treatment:

Drug: Dymista™ Nasal Spray

Placebo Nasal Spray

Placebo Comparator group

Description:

The placebo was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number KL0781, Expiry Date Mar 2015.

Treatment:

Drug: Placebo