Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays

NCT01702103 | Unknown Phase 3

• 1 other identifier: PHT-01-12
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Nasal Obstruction; Sneezing; Itching

Outcome Measures

Primary Outcomes (1)

• 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).

  8 weeks

Secondary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

Mometasone

EXPERIMENTAL

Mometasone, nasal spray for 8 weeks, 2 actuations each nostril in the morning.

Drug: Mometasone furoate

Nasonex®

ACTIVE COMPARATOR

Nasonex nasal spray for 8 weeks 2 actuations each nostril in the morning.

Drug: Mometasone furoate

Interventions

Mometasone furoate DRUG

Mometasone; Nasonex®

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PH&T S.p.A.: lead

Study Sites (1)

Swiss Medical Group

Buenos Aires, Buenos Aires F.D., C1118AAE, Argentina

Location

Related Publications (1)

• Sastre J, Mosges R. Local and systemic safety of intranasal corticosteroids. J Investig Allergol Clin Immunol. 2012;22(1):1-12.

  PMID: 22448448 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction; Sneezing; Pruritus

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alessandro Mazzetti, MD

  Sintesi Research Srl

  STUDY DIRECTOR

Central Study Contacts

Josè Eg Fabiani, Doctor

CONTACT

(00 54 11) 4983-1228

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: October 5, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

AR (1)