“Sleep disturbances in subjects with asthma and rhinitis”

" A double blind, randomised, placebo controlled, cross-over, intervention study evaluating the effect of treating rhinitis in asthma with intranasal steroids to improve sleep.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000095561

Enrollment

Registered

2006-03-09

Start date

2006-03-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A majority of patients with asthma has nasal inflammation but it is not always diagnosed and treated. Nasal inflammation cause sleep disturbances that can be improved by treatment with nasal steroid spray. It has not been studied before if treatment with nasal steroids can improve sleep in patients with asthma. We will investigate 30 patients with asthma to see if their "quality of sleep" and "quality of life" can be improved by treament with nasal steroid spray compared to placebo.

Interventions

6 weeks of intranasal Fluticasone spray 400 ug daily

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Previous studies show that nearly 100% of patients with asthma also have a nasal inflammation (rhinitis) as part of their generalised airway inflammation, but not all asthma patients have symptoms from their nose. This study, however, evaluates if antiinflammatory treatment of the nose have an effect on sleep, regardless of nasal symptoms or not.Inclusion: medically diagnosed asthma.

Exclusion criteria

Pre-existing treatment with nasal steroids which is not able to be stoppedKnown obstructive sleep apnoea syndrome (OSAS)Treatment with oral steroidsPrevious hospitalisation (within the last 12 months) for asthmaInhaled steroid dosage exceeding 1000µg/day (fluticasone) or 1600ug/day (budesonide)Treatment with sedativesTreatment with neuroleptic pharamceuticalsNasal polypsSevere septal deviation or turbinate hypertrophy.

Outcome results