Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays (PHT-01-12)
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Purpose
Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).
| Condition | Intervention | Phase |
|---|---|---|
|
Nasal Obstruction Sneezing Itching |
Drug: Mometasone furoate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED, CLINICAL STUDY TO DEMONSTRATE THE THERAPEUTIC CLINICAL EQUIVALENCE OF TWO MOMETASONE NASAL SPRAYS IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS. |
- demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Safety monitoring AE, routine laboratory haematology, biochemical tests, urinalysis, assessment of adrenal function to be sure of lack of systemic effect of nasal spray formulation Overall Patient's and Physician's global assessment. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Patients at week 8 with a 50% reduction in TNSS mean change from baseline. Symptom-free days. The mean change from baseline to week 8 for mean Total Non Nasal Symptom Scores (TNNSS).
Use of rescue medication (Time Frame: 8 weeks). Individual patient-rated symptoms evaluation. Clinical Global Improvement (CGI) evaluation.
Treatment compliance:
That includes description of the patient's adherence to the optimal prolonged treatment.
| Estimated Enrollment: | 360 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mometasone
Mometasone, nasal spray for 8 weeks, 2 actuations each nostril in the morning.
|
Drug: Mometasone furoate |
|
Active Comparator: Nasonex®
Nasonex nasal spray for 8 weeks 2 actuations each nostril in the morning.
|
Drug: Mometasone furoate |
Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female, 12 years until 65 years old. Subjects with a minimum of 2 years of previous history of perennial allergic rhinitis to at least one perennial allergen 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.
Subjects with perennial allergic rhinitis documented in writing positive allergic skin (a wheal >3mm) test or positive RAST test, performed at screening or within the past 12 months.
A score of at least 6 on the TNSS 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.
Subjects capable of recording nasal allergy diary every day.
Exclusion Criteria:
Females who are pregnant, lactating or plan to get 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 (i.e. infectious sinusitis, hypertrophic rhinitis), 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 systemic infections within the previous 30 days.
Patients previously treated with mometasone within the previous 30 days Patients who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous 2 years or are still receiving this kind of therapy.
Patients with a history of tuberculosis. Patients with glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection.
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.
Contacts and Locations| Contact: Josè Eg Fabiani, Doctor | (00 54 11) 4983-1228 |
| Argentina | |
| Swiss Medical Group | Not yet recruiting |
| Buenos Aires, Capital Federal, Argentina, C1118AAE | |
| Contact: Carlos DEBASA, Dr. 0810-333-8876 | |
| Principal Investigator: Carlos Debasa, Doctor | |
| Study Director: | Alessandro Mazzetti, MD | Sintesi Research Srl |
More Information
Publications:
| Responsible Party: | PH&T S.p.A. |
| ClinicalTrials.gov Identifier: | NCT01702103 History of Changes |
| Other Study ID Numbers: | PHT-01-12 |
| Study First Received: | September 12, 2012 |
| Last Updated: | October 4, 2012 |
| Health Authority: | Argentina: Ministry of Health Peru: Instituto Nacional de Salud |
Additional relevant MeSH terms:
|
Nose Diseases Nasal Obstruction Rhinitis, Allergic, Perennial Sneezing Respiratory Tract Diseases Airway Obstruction Respiratory Insufficiency Respiration Disorders Otorhinolaryngologic Diseases Rhinitis Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Signs and Symptoms, Respiratory Signs and Symptoms Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013