N/A
Completed N=36
DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
Source: ClinicalTrials.gov NCT01184118 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. — 8; 8; 2 participants
Summary
This study is being conducted to find out if the use of inhaled corticosteroids has an affect on upper airway (UAW) collapsibility and sleep apnea risk. An inhaled corticosteroid is a common asthma controller medication like Flovent. Sleep apnea or sleep deprived breathing (SDB) is when someone stops breathing for a short period of time during sleep. For some reason, people with asthma have more sleep apnea and upper airway (UAW) collapsibility (weakness) than the general population. There are many possible reasons for this and one might be related to the use of inhaled corticosteroids.
The overall hypothesis of this study is to determine whether inhaled fluticasone propionate (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as a potential underlying mechanism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. |
8; 8; 2 | — |
| SECONDARY Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment. |
8; 8; 2 | — |
| SECONDARY Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. |
8; 8; 2 | — |
Eligibility Criteria
Inclusion Criteria
- age 18-65;
- history consistent with asthma
- symptoms consistent with NAEPP26 asthma severity step ≥2 (in the past 2-4 weeks, presence of any of the following: daytime symptoms >2 days/week; or nighttime symptoms 3-4x/month; or short acting bronchodilator use (not for prevention of exercise induced asthma) >2 days/week, requiring addition on a controller therapy, using the NAEPP Asthma Step Categorization guidelines
- FEV1≥65%
- confirmation of asthma diagnosis by bronchodilator reversibility (≥12% improvement in FEV1 from baseline following 2 puffs of a β-2 agonist) or a provocative concentration of methacholine needed to produce a 20% fall in FEV1 (PC20) of ≤ 8 mg/ml.
Exclusion Criteria
- any use of inhaled corticosteroid for >2 weeks at a time during the last 6 months, or any use in the last 6 weeks
- as needed use of nasal steroids in the prior 6 months (regular use is allowed without washout needed prior to testing visits)
- use of medications listed in Table 1. Inhaled long acting β-adrenergics are permitted for entry and should be continued during this study
- respiratory infection during the prior 4 weeks or asthma exacerbation during the prior 6 weeks to enrollment
- presence of other lung diseases
- evidence of significant medical (such as angina, heart failure, stroke) or psychiatric illnesses
- diagnosed osteopenia (on treatment) or osteoporosis
- established diagnosis of neuromuscular disease (e.g. multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis (ALS), poliomyelitis, Lambert Eaton syndrome, Guillain-Barre syndrome, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
- BMI greater than 35 kg/m2
- currently on treatment for OSA
- new diagnosis of OSA if OAI > 10/hour or desaturation 1pack/month or cigars in the year before study or overall tobacco use greater than 10 pack years
- inability to abstain from alcohol ingestion for 24 hours prior to sleep studies
- any current use of benzodiazepins, opioids or barbiturates; 16) any current use of recreational drugs.
Data sourced from ClinicalTrials.gov (NCT01184118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.