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NCT Number: NCT01038427

A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Austin, Texas, United States

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About this study

The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 200 mcg was 4 actuations, each containing 50 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
  • Signed informed consent form. For patients under the age of majority the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form.
  • Documented positive allergic skin test to local pollen, performed within the past 12 months.
  • A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms.

Exclusion criteria

  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • History of asthma over the previous two years that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
  • Patients with some nasal conditions, or with clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
  • Upper respiratory tract infection or any untreated infections within the previous 30 days.
  • Patient has started immunotherapy/changed the dose within 30 days of starting the study or has desensitization therapy to the seasonal allergen that is causing the allergic rhinitis within the previous 6 months.
  • Patients with a history of tuberculosis, or with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of seasonal allergic rhinitis within 14 days of enrollment.
  • The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox or measles.
  • Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
  • Planned travel outside of the local area for more than 2 consecutive days or 3 days in total.
  • The patient has a history of alcohol or drug abuse.

Treatment and study plan

Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)

Drug

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray

Drug

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Placebo

Drug

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Primary outcomes

  1. Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)

    Time frame: Baseline, 14 days

    Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.

    Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.

    Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.

  2. Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)

    Time frame: Baseline, 14 days

    Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.

    Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.

    Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.

Secondary outcomes

  1. Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)

    Time frame: Baseline, 14 days

    Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.

    Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.

    Mean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.

  2. Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)

    Time frame: Baseline, 14 days

    Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.

    Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.

    Mean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.

  3. Clinical Global Improvement Based on the Investigator's Assessment

    Time frame: Day 15

    A global evaluation of efficacy relative to baseline was assessed separately by the investigator and the patient on Day 15. Both the investigator and the patient were asked to rate clinical improvement since baseline on a 5-category scale ranging from "No Relief" to "Complete Relief" of signs and symptoms of seasonal allergic rhinitis. This record shows the clinical global improvement based on the investigator's assessment.

  4. Clinical Global Improvement Based on the Patient's Assessment

    Time frame: Day 15

    A global evaluation of efficacy relative to baseline was assessed separately by the investigator and the patient on Day 15. Both the investigator and the patient were asked to rate clinical improvement since baseline on a 5-category scale ranging from "No Relief" to "Complete Relief" of signs and symptoms of seasonal allergic rhinitis. This record shows the clinical global improvement based on the patient's assessment.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 24, 2009
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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