Rhinitis AllergicPhase 3NASANIFNCT03317015
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)
A Phase 3 study testing triamcinolone XRG5029 and fluticasone in people with Rhinitis Allergic, run by Sanofi.
Trial summary
Primary Objective: To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- triamcinolone XRG5029 and fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2016to 10 Jul 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Females and males ≥18 and ≤50 years old.
- Patients with previously diagnosed PAR with a positive skin prick test response to an appropriate allergen performed not earlier than 12 months prior to the Screening visit.
- Patients must be clinically symptomatic (rTNSS reflecting symptoms for the previous 24 h ≥8 with two or more symptoms rated as moderate or severe).
- Negative urine pregnancy test during screening before first dose of study medication is administered in women with child-bearing potential.
- Women must use an effective contraceptive method during the study period.
- Patients should be able to understand the study, including risks and adverse events; collaborating with Investigator and proceed according with protocol.
- Signed informed consent form.
Who cannot join
- Compromised ability to provide informed consent.
- Participation in any other clinical study.
- History of severe local reaction(s) or anaphylaxis to skin testing.
- Upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or viral upper respiratory infection within 2 weeks prior to the Screening Visit.
- Subjects who have used any drug (Flixonase or Nasacort) in an investigational protocol 4 weeks prior to the Screening Visit.
- Female subjects who are breast-feeding, pregnant, or intend to become pregnant.
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- Patients with nasal abnormalities, including nasal polyps, and marked septum deviation that interferes with nasal airflow.
- Recent (in the last 3 months) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma.
- Specific immunotherapy finished later than 6 months prior to Visit 1.
- Use of following medications:
- Intranasal corticosteroids within 4 weeks prior to Visit 1;
- Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid within 8 weeks prior to Visit 1;
- Cromones within 2 weeks prior to Visit 1;
- Short-acting antihistamines, including antihistamines contained in insomnia formulations within 3 days prior to Visit 1;
- Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine;
- Intranasal antihistamines within 2 weeks prior to Visit 1;
- Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1;
- Oral antileukotrienes within 3 days prior to Visit 1;
- Use of immunosuppressive medications 8 weeks prior to screening.
- Patients allergic to or have sensitivity to the study drug (triamcinolone acetonide, fluticasone propionate) or its excipients.
- Patients suffering from SAR (seasonal allergic rhinitis).
- Patients suffering from non-allergic rhinitis.
- Patients suffering from rhinitis medicamentosa.
- Patients suffering from non-allergic rhinitis caused by viral, bacterial etc infection.
- Patients suffering from bronchial asthma.
- Patients suffering from chronic sinusitis.
- In case of non-allergic rhinitis, nasal trauma or other condition that during the study can interfere with symptoms evaluation, subject would be excluded from the study.
- Patients with physical impairment that would affect subject's ability to participate safely and fully in the study.
- Clinical evidence of a Candida infection of the nose.
- History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would affect the proper daily diary filling.
- Previous history and/or current diagnosis of glaucoma and cataract.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison With Flixonase® Nasal Spray (Fluticasone, 50 µg) in Adults Suffering From PAR (Perennial Allergic Rhinitis) Administered Once a Day for 28 Days
Primary Objective:
- To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis).
Read more
Secondary Objectives:
- To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports.
- To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale.
- To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).
Read the detailed description
The total study duration per patient will be up to approximately 33 days.
- Conditions
- Rhinitis Allergic
- Being tested
- triamcinolone XRG5029, fluticasone
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone XRG5029Drug
Also called Nasacort®
Pharmaceutical form: spray solution
Route of administration: nasal
fluticasoneDrug
Also called Flixonase®
Pharmaceutical form: spray solution
Route of administration: nasal
| Study group | Role | What they receive |
|---|---|---|
| Group A - Nasacort® | Experimental | Nasacort® will be sprayed twice in each nostril once every morning Receives: Drug: triamcinolone XRG5029 |
| Group B - Flixonase® | Active comparator | Flixonase® will be sprayed twice in each nostril once every morning Receives: Drug: fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total nasal symptom score
Measured: From baseline (0 day of treatment) to 28th day of treatment
Secondary outcomes (4)
Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire)
Measured: From baseline (0 day of treatment) to 28th day of treatment
Number of participants with adverse events
Measured: From baseline (0 day of treatment) to 28th day of treatment
Assessment of patient satisfaction using the 5-point scale questionnaire
Measured: 28th day of treatment
Assessment of physician satisfaction using the 5-point scale questionnaire
Measured: 28th day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start30 Nov 2016
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis AllergicStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317015
- Sponsor's protocol ID
- TRICAL07830
- Other IDs
- U1111-1178-4882
- Acronym
- NASANIF
- Status last verified
- Apr 2022
- First submitted
- 18 Oct 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison With Flixonase® Nasal Spray (Fluticasone, 50 µg) in Adults Suffering From PAR (Perennial Allergic Rhinitis) Administered Once a Day for 28 Days
- ClinicalTrials.gov ID
- NCT03317015
- Acronym / sponsor ID
- NASANIF / TRICAL07830
- Conditions
- Rhinitis Allergic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
Primary Objective:
- To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis).
Secondary Objectives:
- To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports.
- To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale.
- To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).
Detailed description
The total study duration per patient will be up to approximately 33 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Nasacort® | Experimental | Drug: triamcinolone XRG5029Nasacort® will be sprayed twice in each nostril once every morning |
| Group B - Flixonase® | Active comparator | Drug: fluticasoneFlixonase® will be sprayed twice in each nostril once every morning |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females and males ≥18 and ≤50 years old.
- Patients with previously diagnosed PAR with a positive skin prick test response to an appropriate allergen performed not earlier than 12 months prior to the Screening visit.
- Patients must be clinically symptomatic (rTNSS reflecting symptoms for the previous 24 h ≥8 with two or more symptoms rated as moderate or severe).
- Negative urine pregnancy test during screening before first dose of study medication is administered in women with child-bearing potential.
- Women must use an effective contraceptive method during the study period.
Key exclusion criteria (32 listed)
- Compromised ability to provide informed consent.
- Participation in any other clinical study.
- History of severe local reaction(s) or anaphylaxis to skin testing.
- Upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or viral upper respiratory infection within 2 weeks prior to the Screening Visit.
- Subjects who have used any drug (Flixonase or Nasacort) in an investigational protocol 4 weeks prior to the Screening Visit.
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 XRG5029Also: Nasacort®Pharmaceutical form: spray solution Route of administration: nasal | Drug | Group A - Nasacort® |
| fluticasoneAlso: Flixonase®Pharmaceutical form: spray solution Route of administration: nasal | Drug | Group B - Flixonase® |
Primary outcome
Change from baseline in total nasal symptom score
Time frame: From baseline (0 day of treatment) to 28th day of treatment
4 secondary outcomes
Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire)
Time frame: From baseline (0 day of treatment) to 28th day of treatment
Number of participants with adverse events
Time frame: From baseline (0 day of treatment) to 28th day of treatment
Assessment of patient satisfaction using the 5-point scale questionnaire
Time frame: 28th day of treatment
Assessment of physician satisfaction using the 5-point scale questionnaire
Time frame: 28th day of treatment
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 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing triamcinolone XRG5029 and fluticasone in people with Rhinitis Allergic, run by Sanofi.
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 7 inclusion and 32 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 25 Apr 2022. 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. 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?
Change from baseline in total nasal symptom score (time frame: From baseline (0 day of treatment) to 28th day of treatment). 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 25 Apr 2022.