NCT00590772

Brief Summary

The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

October 21, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

5.7 years

First QC Date

December 26, 2007

Results QC Date

July 21, 2009

Last Update Submit

October 20, 2014

Conditions

Perennial Allergic Rhinitis

Keywords

sleepsomnolenceallergiesrhinitisfatigue

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks

    Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe. To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement. To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement. For all three above we used data from the last 3 days were averaged and mean of change for each day.

    baseline and 2 weeks

Study Arms (2)

montelukast

ACTIVE COMPARATOR

montelukast 10 mg daily

Drug: montelukast

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: placebo

Interventions

montelukastDRUG

10 mg po each day (compared to placebo for 2 weeks)

Also known as: Singulair
montelukast
placeboDRUG

placebo for 2 weeks

Placebo

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 16 to 65.
  • History of allergic rhinitis.
  • The ability to be placed on placebo without significant compromise in the quality of life.
  • General good health.
  • Ability to comply with the protocol and sign an informed consent.
  • Have daytime sleepiness by history.
  • Have poor sleep by history.
  • Have fatigue by history.
  • Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.

You may not qualify if:

  • Age fewer than 16 or over 65 years.
  • A history of sleep apnea.
  • Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.
  • Non-allergic rhinitis.
  • Obesity.
  • Inability to tolerate montelukast.
  • Significant other diseases as determined by the investigator.
  • Use of a research medication within 30 days.
  • Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
  • Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
  • Excessive use of alcohol or drug abuse.
  • Inability to stop medication use during run-in period.
  • Use of an oral antihistamine within 1 week of enrollment.
  • Failed to have benefit when montelukast was used for rhinitis or asthma in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Santos CB, Hanks C, McCann J, Lehman EB, Pratt E, Craig TJ. The role of montelukast on perennial allergic rhinitis and associated sleep disturbances and daytime somnolence. Allergy Asthma Proc. 2008 Mar-Apr;29(2):140-5. doi: 10.2500/aap.2008.29.3097.

    PMID: 18430310RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialSleepinessHypersensitivityRhinitisFatigue

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis, AllergicNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfections

Results Point of Contact

Title
Timothy Craig
Organization
Penn State University
tcraig@psu.edu
717-531-6525

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

May 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 21, 2014

Results First Posted

October 21, 2014

Record last verified: 2014-10