Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED)

NCT00491374 | Terminated Phase 4 Results

• 1 other identifier: P04909
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will hope to show that the treatment of the patient's perennial allergic rhinitis (PAR) using Nasonex® (mometasone furoate nasal spray) will result in improvement of the nasal symptoms of PAR and of nighttime sleep-disordered breathing, thereby resulting in improved sleep quality, less daytime sleepiness, improved daytime functioning, and improved quality of life.

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)

Study Arms (2)

MFNS

EXPERIMENTAL

Drug: Mometasone Furoate Nasal Spray

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mometasone Furoate Nasal Spray DRUG

Nasonex Nasal Spray 50 mcg/spray, 200 mcg (4 sprays) once daily every morning for 28 days.

Also known as: SCH 32088

MFNS

Placebo DRUG

Placebo Nasal Spray 4 sprays once daily every morning for 28 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be 18 to 45 years of age, of either sex, and any race.
• Must have at least a 2-year history of PAR.
• Must be skin test positive for the usual allergens associated with PAR within the previous 12 months with regular exposure to at least one of the allergens to which the subject is allergic.
• Must be sufficiently symptomatic at the Screening Visit (Visit 1), Qualification Visit (Visit 2), and Baseline Visit (Visit 4) with a minimal level of PRIOR (reflective) total symptom score, total nasal symptoms score, and total non-nasal symptoms score in order to qualify.
• At the Qualification Visit 2, subjects must have a score of at least 2 with the Interference with Sleep severity rating score for at least 3 of the 7 nights prior to the Qualification visit.
• At the Baseline Visit 4 subjects must have a score of at least 2 with the Interference with Sleep severity rating score for at least 1 of the 3 nights prior to the Baseline Visit.
• Must have an apnea-hypopnea index (AHI) of \>=5, but not more than 30, during the first screening polysomnographic evaluation and to proceed to the second polysomnographic evaluation.
• At the Baseline Visit (Visit 4), the subjects must complete the NRQLQ, PQSI, ESS, WPAI-AS.
• Must complete the PVT within 1 hour of bedtime and 1 hour of arising on the nights when the PSGs are done.
• Female subjects of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for \>1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.
• Female subjects of childbearing potential must have a negative urine pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Visit 4 confirmed prior to dosing with the study drug and at final Visit 7.

You may not qualify if:

• Subject has symptomatic seasonal allergic rhinitis (SAR) or a history of SAR during the same calendar period as this study.
• Subject is a female who is pregnant, or intends to become pregnant during the study.
• Subject is nursing, or intends to be nursing during the study.
• Subject has used any investigational product within 30 days prior to enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days).
• Subject has any of the following clinical conditions:
• known severe sleep apnea
• asthma
• chronic obstructive pulmonary disease (COPD)
• alcohol abuse
• rhinitis medicamentosa
• Subject is currently on or has been on an antihistamine, decongestant (topical or systemic) or a nasal inhaled corticosteroid during the 14 days prior to the Screening Visit.
• Subject with current or history of frequent episodes (2 or more episodes per year for the past 2 years) of clinically significant sinusitis or chronic purulent postnasal drip.
• Subject has had recent nasal septum ulcers, nasal surgery, or nasal trauma.
• Subject has had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to screening, or who has had a viral upper or lower respiratory infection within 14 days prior to screening.
• Subject has nasal structural abnormalities, including large nasal polyps, and marked septum deviation that significantly interfere with nasal airflow.

Sponsors & Collaborators

• Schering-Plough: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was difficult to enroll subjects, and after 5 months of screening, the screen failure rate was 100%. At that time the decision was made to terminate the study. No subject was treated and no data were collected.

Results Point of Contact

• Title: Head, Clinical Trials Registry & Results Disclosure Group
• Organization: Schering-Plough

ClinicalTrialsDisclosure@spcorp.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: September 1, 2006
• Study Completion: October 1, 2007
• Last Updated: January 6, 2009
• Results First Posted: January 6, 2009

Record last verified: 2009-01