Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays (PHT-01-12)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by PH&T S.p.A.
Sponsor:
Information provided by (Responsible Party):
PH&T S.p.A.
ClinicalTrials.gov Identifier:
NCT01702103
First received: September 12, 2012
Last updated: October 4, 2012
Last verified: October 2012
  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.

Resource links provided by NLM:


Further study details as provided by PH&T S.p.A.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702103

Contacts
Contact: Josè Eg Fabiani, Doctor (00 54 11) 4983-1228

Locations
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         
Sponsors and Collaborators
PH&T S.p.A.
Investigators
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
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2014