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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) (NASANIF)

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ClinicalTrials.gov Identifier: NCT03317015
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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 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).

Condition or disease Intervention/treatment Phase
Rhinitis Allergic Drug: triamcinolone XRG5029 Drug: fluticasone Phase 3

Detailed Description:
The total study duration per patient will be up to approximately 33 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017


Arm Intervention/treatment
Experimental: Group A - Nasacort®
Nasacort® will be sprayed twice in each nostril once every morning
Drug: triamcinolone XRG5029

Pharmaceutical form: spray solution

Route of administration: nasal

Other Name: Nasacort®

Active Comparator: Group B - Flixonase®
Flixonase® will be sprayed twice in each nostril once every morning
Drug: fluticasone

Pharmaceutical form: spray solution

Route of administration: nasal

Other Name: Flixonase®




Primary Outcome Measures :
  1. Change from baseline in total nasal symptom score [ Time Frame: From baseline (0 day of treatment) to 28th day of treatment ]

Secondary Outcome Measures :
  1. Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire) [ Time Frame: From baseline (0 day of treatment) to 28th day of treatment ]
  2. Number of participants with adverse events [ Time Frame: From baseline (0 day of treatment) to 28th day of treatment ]
  3. Assessment of patient satisfaction using the 5-point scale questionnaire [ Time Frame: 28th day of treatment ]
  4. Assessment of physician satisfaction using the 5-point scale questionnaire [ Time Frame: 28th day of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317015


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03317015     History of Changes
Other Study ID Numbers: TRICAL07830
U1111-1178-4882 ( Other Identifier: UTN )
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors