Seasonal Allergic RhinitisPhase 2NCT02279563
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
A Phase 2 study testing Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray and Dymista™ Nasal Spray in people with Seasonal Allergic Rhinitis, run by Apotex Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray and Dymista™ Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 595 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who met all of the following criteria were eligible for inclusion in the study:
- Subjects who provided written informed consent.
- Subjects who were able to read and understand English.
- Males or females, 18 to 65 years old, inclusive.
- 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.
- At least a 2-year reliable medical history consistent with SAR, defined as symptoms present during the previous two grass and/or pollen seasons.
Show all 11Show fewer
- 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.
- Was capable of tolerating intranasal application of the study drug.
- No clinically significant results from the screening physical examination, nasal examination, and medical history.
- 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.
- Was, in the Investigator's judgment (through exposure to allergen), expected to require treatment throughout the entire study period.
Who cannot join
- Subjects who met any of the following criteria were excluded from the study:
- 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.
- Underwent nasal surgery or had nasal trauma within 3 months of Visit 1 (screening).
- 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.
- Had PAR that required or was expected to require active PAR treatment during the study period.
- Had a respiratory tract infection (including otitis media and streptococcus) that required antibiotic treatment within 2 weeks of Visit 1 (screening).
- 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
About this study
Official title: A Randomized, Double-blind, Placebo-controlled,Parallel-group 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
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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray, Dymista™ Nasal Spray, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per sprayDrug
During the placebo lead-in period, the placebo nasal spray was administered via nasal inhalation with one spray in each nostril twice daily for 7days.
During the randomized treatment period, the investigational products (experimental, active comparator and placebo nasal spray) were administered via nasal inhalation with one spray in each nostril twice daily for 14 days
Dymista™ Nasal SprayDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Azelastine HCl and Fluticasone Propionate Nasal Spray | Experimental | The investigational product was administered via nasal inhalation with one spray in each nostril twice daily.
Batch Number KL1981, Expiry Date Mar 2015. Receives: Drug: Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray |
| Dymista™ Nasal Spray | Active comparator | The reference product was administered via nasal inhalation with one spray in each nostril twice daily.
Batch Number G30349, Expiry Date Mar 2015. Receives: Drug: Dymista™ Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | The placebo was administered via nasal inhalation with one spray in each nostril twice daily.
Batch Number KL0781, Expiry Date Mar 2015. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined reflective TNSS (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing)
Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.
Measured: 2 months
Secondary outcomes (1)
Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.)
Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apotex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279563
- Sponsor's protocol ID
- AZFL-NASU-05RB02-CE
- Status last verified
- Oct 2014
- First submitted
- 28 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled,Parallel-group 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
- ClinicalTrials.gov ID
- NCT02279563
- Acronym / sponsor ID
- AZFL-NASU-05RB02-CE
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Apotex Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azelastine HCl and Fluticasone Propionate Nasal Spray | Experimental | Drug: Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per sprayThe investigational product was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number KL1981, Expiry Date Mar 2015. |
| Dymista™ Nasal Spray | Active comparator | Drug: Dymista™ Nasal SprayThe reference product was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number G30349, Expiry Date Mar 2015. |
| Placebo Nasal Spray | Placebo comparator | Drug: PlaceboThe placebo was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number KL0781, Expiry Date Mar 2015. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects who provided written informed consent.
- Subjects who were able to read and understand English.
- Males or females, 18 to 65 years old, inclusive.
- 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.
- At least a 2-year reliable medical history consistent with SAR, defined as symptoms present during the previous two grass and/or pollen seasons.
Key exclusion criteria (7 listed)
- 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.
- Underwent nasal surgery or had nasal trauma within 3 months of Visit 1 (screening).
- 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.
- Had PAR that required or was expected to require active PAR treatment during the study period.
- Had a respiratory tract infection (including otitis media and streptococcus) that required antibiotic treatment within 2 weeks of Visit 1 (screening).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per sprayDuring the placebo lead-in period, the placebo nasal spray was administered via nasal inhalation with one spray in each nostril twice daily for 7days. During the randomized treatment period, the investigational products (experimental, active comparator and placebo nasal spray) were administered via nasal inhalation with one spray in each nostril twice daily for 14 days | Drug | Azelastine HCl and Fluticasone Propionate Nasal Spray |
| Dymista™ Nasal Spray | Drug | Dymista™ Nasal Spray |
| Placebo | Drug | Placebo Nasal Spray |
Primary outcome
Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined reflective TNSS (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing)
Time frame: 2 months
Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.
1 secondary outcome
Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray and Dymista™ Nasal Spray in people with Seasonal Allergic Rhinitis, run by Apotex Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined reflective TNSS (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.