Perennial Allergic RhinitisPhase 4NCT00491374

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

A Phase 4 study testing Mometasone Furoate Nasal Spray in people with Perennial Allergic Rhinitis, run by Schering-Plough.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Perennial Allergic Rhinitis
What is being tested?: Mometasone Furoate Nasal Spray
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Sep 2006to Oct 2007
Phase: Phase 4
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 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

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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.

Who cannot join

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

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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.
Subject is unable to refrain from regular use of nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Subject on immunotherapy (desensitization therapy) should not receive an increase in dose during the study. Subjects may not receive desensitization treatment within 24 hours prior to a study visit.
Subject has active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex.
Subject is morbidly obese (BMI >=35).
Subject is a night-shift worker and does not have a standard asleep at night / awake during the day cycle, or has an irregular sleep/wake schedule.
Subject reports routinely spending less than 6 1/2 hours of time in bed per night.
Subject reports drinking 3 or more cups of regular coffee or 4 or more 8 ounce cans/bottles of caffeine-containing carbonated beverages per 24 hour period.

About this study

Official title: A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study Of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Mild-Moderate Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) Associated With Perennial Allergic Rhinitis (PAR) Using Polysomnographic Recordings of Sleep Parameters

Conditions: Perennial Allergic Rhinitis
Being tested: Mometasone Furoate Nasal Spray, Placebo
Medical subject headings: Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mometasone Furoate Nasal SprayDrug
Also called SCH 32088
Nasonex Nasal Spray 50 mcg/spray, 200 mcg (4 sprays) once daily every morning for 28 days.
PlaceboDrug
Placebo Nasal Spray 4 sprays once daily every morning for 28 days.

Study groups in NCT00491374
Study group	Role	What they receive
MFNS	Experimental	Not described Receives: Drug: Mometasone Furoate Nasal Spray
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

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

Timeline

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

Sep 2006Oct 2007

First posted26 Jun 2007 (estimated)
Study startSep 2006
Study completionOct 2007

Why it stopped: Very poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00491374
Sponsor's protocol ID: P04909
Status last verified: Jan 2009
First submitted: 25 Jun 2007
Last updated: 6 Jan 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

All Perennial Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study Of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Mild-Moderate Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) Associated With Perennial Allergic Rhinitis (PAR) Using Polysomnographic Recordings of Sleep Parameters
ClinicalTrials.gov ID: NCT00491374
Acronym / sponsor ID: P04909
Conditions: Perennial Allergic Rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Very poor enrollment
Enrolment: 0 participants (actual)
Lead sponsor: Schering-PloughIndustry (pharma, biotech, devices)
Study start: Sep 2006
Study completion: Oct 2007 (actual)
First posted: 26 Jun 2007 (estimated)
Results: Posted 6 Jan 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MFNS	Experimental	Drug: Mometasone Furoate Nasal Spray
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (22 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mometasone Furoate Nasal SprayAlso: SCH 32088Nasonex Nasal Spray 50 mcg/spray, 200 mcg (4 sprays) once daily every morning for 28 days.	Drug	MFNS
PlaceboPlacebo Nasal Spray 4 sprays once daily every morning for 28 days.	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 6 Jan 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	0	0
Mometasone Furoate Nasal Spray	0	0

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

Number

Measure	Placebo n = 0	Mometasone Furoate Nasal Spray n = 0
Value	0	0

Population analysed: The primary outcome measure could not be assessed because no subject received randomized treatment assignment, or any treatment. The study was terminated.

Adverse events

Other adverse events reported at any% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of ?	0 of ?	Not reported
Mometasone Furoate Nasal Spray	0 of ?	0 of ?	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Perennial Allergic Rhinitis

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mometasone Furoate Nasal Spray in people with Perennial Allergic Rhinitis, run by Schering-Plough.

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 11 inclusion and 22 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: stopped early, as of the sponsor's last update on 6 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 6 Jan 2009). 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?

The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI). 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 NCT00491374.

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 6 Jan 2009.