Seasonal Allergic RhinitisPhase 3NCT00987233
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
A Phase 3 study testing triamcinolone acetonide aqueous nasal spray (Apotex Inc.) and triamcinolone acetonide aqueous nasal spray (Nasacort® AQ) in people with Seasonal Allergic Rhinitis, run by Apotex Inc. at 1 site in United States.
Trial summary
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. 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?
- triamcinolone acetonide aqueous nasal spray (Apotex Inc.) and triamcinolone acetonide aqueous nasal spray (Nasacort® AQ)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinsys Clinical Research, Inc.
Bedminster, New Jersey, 07921
About this study
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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- triamcinolone acetonide aqueous nasal spray (Apotex Inc.), triamcinolone acetonide aqueous nasal spray (Nasacort® AQ), 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.
triamcinolone acetonide aqueous nasal spray (Apotex Inc.)Drug
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.
triamcinolone acetonide aqueous nasal spray (Nasacort® AQ)Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| triamcinolone acetonide aqueous nasal spray | Experimental | Not described Receives: Drug: triamcinolone acetonide aqueous nasal spray (Apotex Inc.) |
| Nasacort® AQ Nasal Spray | Active comparator | Not described Receives: Drug: triamcinolone acetonide aqueous nasal spray (Nasacort® AQ) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Apotex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987233
- Sponsor's protocol ID
- TRIA-NASO-05RB02-CE
- Status last verified
- Sep 2009
- First submitted
- 29 Sep 2009
- Last updated
- 30 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00987233
- Acronym / sponsor ID
- TRIA-NASO-05RB02-CE
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Apotex Inc.Industry (pharma, biotech, devices)
- First posted
- 30 Sep 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| triamcinolone acetonide aqueous nasal spray | Experimental | Drug: triamcinolone acetonide aqueous nasal spray (Apotex Inc.) |
| Nasacort® AQ Nasal Spray | Active comparator | Drug: triamcinolone acetonide aqueous nasal spray (Nasacort® AQ) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
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 |
|---|---|---|
| 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. | Drug | triamcinolone acetonide aqueous nasal spray |
| 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. | Drug | Nasacort® AQ Nasal Spray |
| PlaceboIt 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. | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing triamcinolone acetonide aqueous nasal spray (Apotex Inc.) and triamcinolone acetonide aqueous nasal spray (Nasacort® AQ) in people with Seasonal Allergic Rhinitis, run by Apotex Inc. at 1 site in United States.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.. 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 30 Sep 2009.