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Seasonal Allergic RhinitisPhase 3NCT01850823

Clinical Equivalence Study of Mometasone Nasal Spray

A Phase 3 study testing Mometasone Nasal Spray in people with Seasonal Allergic Rhinitis, run by Actavis Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Watson Laboratories, Inc) with NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Seasonal Allergic Rhinitis
What is being tested?
Mometasone Nasal Spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
880 participants
Where
25 sitesUnited States
Study dates
Feb 2013to Dec 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or non-pregnant non-lactating female
  • 12 years of age or older
  • Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form that will be written in such a way as to be understandable to a child.
  • If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives). In order for hormonal birth control to be considered a reliable method the patient must have been on their regimen for at least 28 days.
  • Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
  • A minimum of two consecutive years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
  • A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and 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 (see Appendix A) representing the 12 hours prior to the screening visit.
  • An average composite score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and 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 (see Appendix A) representing the last 3 days of the 7-day placebo run-in period before the randomization visit and the morning of the first day of the randomization visit.

Who cannot join

  • Under 12 years of age.
  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted. The results of all positive skin allergen test results should be reported.
  • Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study unless the Investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR) rather than chronic PAR.
  • Patients who suffer only from perennial allergic rhinitis or seasonal allergic rhinitis to a different allergen than that in season at the time the study is conducted.
  • Previous history of less than 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
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  • A total score of less than 6 on the reflective Total Nasal Symptom Score (rTNSS) or a score less than 2 for "nasal congestion" or a score less than 2 for all 3 of the remaining symptoms (see Appendix A). Any patient who meets the minimum rTNSS requirements at the start of the placebo lead-in period but no longer meets the requirements prior to the randomized active treatment period of the study cannot continue in the active treatment period.
  • History of asthma over the previous two years that required chronic therapy. Occasional acute or mild exercise induced asthma will be allowable on the condition that the treatment of the attacks is restricted to beta-agonists only.
  • Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa or atrophic rhinitis.
  • Clinically significant nasal deformity (e.g. significantly deformed septum, nasal polyps or ulcers) or any recent nasal surgery or trauma that has not completely healed.
  • Sinus infection within the previous 30 days or history of re-occurring sinus infections.
  • Patient has started immunotherapy (including topical or desensitization therapy) or changed their dose of immunotherapy within 30 days of the first placebo lead-in dose or is likely to have to start immunotherapy, or change their current dose during the study.
  • Treatment for oral Candidiasis within 30 days of starting the study or a current oral Candidiasis infection.
  • Upper respiratory tract infection within the previous 30 days.
  • Patients with a history of tuberculosis.
  • Patients with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of SAR 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.
  • Patients with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
  • Use of any ophthalmic steroids within 14 days or nasal, inhaled or systemic steroids within 30 days of the study start. Super or high potency topical steroids should not be used during the study. The use of low potency topical corticosteroids (e.g. OTC 1% hydrocortisone) will be allowed. The use of hormonal contraceptives or hormone replacement therapy is allowed, on condition the patient has been on a stable dosing regimen for at least 28 days prior to the start of the study and remains on the same dosing regimen during the study.
  • Use of intranasal or systemic second-generation anti-histamines (e.g. fexofenadine, loratadine, desloratadine, cetirizine) within 10 days of enrollment.
  • Use of intranasal cromolyn within 14 days of enrollment.
  • Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor antagonists (montelukast) or other nasal decongestants within 3 days of enrollment.
  • Use of any tricyclic anti-depressant within 30 days of enrollment.
  • Patients with attention-deficit disorder being treated with methylphenidate containing products that have not been on a stable dosing regimen for at least the 30 previous days and who cannot remain on the same dosing regimen throughout the study.
  • Desensitization therapy to the seasonal allergen that is causing the patients allergic rhinitis within the previous 6 months.
  • Previous SAR and/or PAR that has proven unresponsive to steroid therapy.
  • Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
  • Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participating or could jeopardize the integrity of the study evaluations.
  • Receipt of any drug as part of a research study within 30 days prior to the first placebo lead-in dose.
  • Planned travel outside of the local area for more than 2 consecutive days or 3 days in total, during the patient's participation in the study.
  • Previous participation in this study.
  • The patient has a history of non-compliance with medication regimens or treatment protocols in previous clinical studies.
  • The patient is a member of the investigational study staff or a member of the family of the investigational study staff.
  • The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker (for example, on average more than 10 cigarettes per day).

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Investigator Site 10

    Austin, Texas

  • Investigator Site 12

    Austin, Texas

  • Investigator site 6

    Austin, Texas

  • Investigator site 22

    Bellevue, Nebraska

  • Investigator site 3

    Bethesda, Maryland

  • Investigator site 25

    Cincinnati, Ohio

  • Investigator site 2

    Corning, New York

  • Investigator Site 15

    Draper, Utah

  • Investigator Site 17

    Greenfield, Wisconsin

  • Investigator site 9

    High Point, North Carolina

  • Investigator Site 11

    Kerrville, Texas

  • Investigator site 1

    Louisville, Kentucky

  • Investigator Site 19

    Minneapolis, Minnesota

  • Investigator Site 7

    New Braunfels, Texas

  • Investigator site 20

    Raleigh, North Carolina

  • Investigator Site 13

    San Antonio, Texas

  • Investigator site 14

    San Antonio, Texas

  • Investigator site 5

    San Antonio, Texas

  • Investigator site 8

    San Antonio, Texas

  • Investigator Site 23

    Skillman, New Jersey

  • Investigator site 16

    Spartanburg, South Carolina

  • Investigator Site 24

    St Louis, Missouri

  • Investigator site 18

    Stockbridge, Georgia

  • Investigator site 21

    Sylvania, Ohio

  • Investigator site 4

    Waco, Texas

Other trials in United States

About this study

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

Being tested
placebo, Mometasone Nasal Spray
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.

  • placeboDrug

  • Mometasone Nasal SprayDrug

  • Mometasone nasal sprayDrug

Study groups in NCT01850823
Study groupRoleWhat they receive
placeboPlacebo comparatorPlacebo
Receives: Drug: placebo
NASONEX® Nasal Spray (Schering Corporation)Active comparatorMometasone Nasal spray
Receives: Drug: Mometasone Nasal Spray
Mometasone Nasal Spray (Watson Laboratories, Inc)ExperimentalMometasone Nasal spray
Receives: Drug: Mometasone nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.

    The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3 : Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose. Measurements were taken twice daily approximately 12 hours apart.

    0= No symptom

    1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated)
    2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable)
    3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)

    Measured: Twice daily from Baseline to 2 weeks

  2. Superiority of Active Treatment Arms Over Placebo

    Superiority analysis of Change From Baseline in rTNSS for both active arms compared to placebo arm. The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3: Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose twice daily approximately 12 hours apart.

    0= No symptom

    1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated)
    2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable)
    3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)

    Measured: Twice daily from Baseline to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01850823
Sponsor's protocol ID
71209805
Status last verified
Aug 2020
First submitted
6 May 2013
Last updated
19 Aug 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mometasone Nasal Spray in people with Seasonal Allergic Rhinitis, run by Actavis Inc. at 25 sites 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 8 inclusion and 34 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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?

Yes. Results are posted in the registry (first posted 19 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. (time frame: Twice daily from Baseline to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01850823.

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 19 Aug 2020.

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