Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)

Romaker & Associates

Status and phase: Completed; Phase 3

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Placebo; Drug: budesonide and montelukast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01089647

Adult OSA drug study

IISP 37206 (Other Grant/Funding Number)

Details and patient eligibility

About

In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.

Full description

40 adults with mild OSA (< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.

Enrollment: 34 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18 - 100 years
• RDI between 5 - 15
• all races
• both sexes

Exclusion criteria

• craniofacial, syndromic, neurological abnormalities
• current or previous use of Singular, Rhinocort within last 6 months
• acute upper respiratory infections
• recent nasal trauma, nasal surgery, nasal septum perforation
• known immunodeficiency or under going immunosuppressant therapy
• current therapy with drugs that interact with Montelukast or Budesonide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

budesonide and montelukast

Active Comparator group

Description:

treatment arm

Treatment:

Drug: budesonide and montelukast

placebo

Placebo Comparator group

Description:

sugar pill, salt water nasal spray

Treatment:

Drug: Placebo