Trial · NCT01184118
DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
NCT01184118, Not applicable, Completed, University of Wisconsin, Madison; results first posted 2016-06-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations? Trials, record NCT01184118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01184118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
- NCT number
- NCT01184118
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 36 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Lung Disease
- Interventions
- FP 220 mcg 2 puffs BID
- First posted
- 2010-08-18
- Last updated
- 2016-09-07
- Results first posted
- 2016-06-13
- Limitations and caveats
- We were unsuccessful at securing placebo MDI, and the lack of a control group raises the possibility that our findings may reflect natural history of pharyngeal upper airway patency in asthma.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. | 16 weeks | Upper airway (UAW) collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes. Subjects were divided into 3 subgroups: improved (more negative Pcrit), unchanged, or worsened (less negative Pcrit). |
| 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. | 16 weeks | Secondary goals include evaluating effects of this medication on severity of obstructive sleep disordered breathing (SDB) (validated by Sleep Disorders Questionnaire (SA-SDQ)). Subjects were divided into 3 subgroups: improved (less negative SA-SDQ score), unchanged, or worsened (more negative SA-SDQ score). |
| Secondary | Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. | 16 weeks | The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth. Anterior tongue strength (KPa) reported. Subjects were divided into 3 subgroups: improved (lower anterior tongue strength KPa), unchanged, or worsened (higher anterior tongue strength KPa). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. | 16 weeks | participants | NUMBER | |
| 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. | 16 weeks | participants | NUMBER | |
| SECONDARY | Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. | 16 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Improved Pcrit over 16 weeks | 8 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Unchanged Pcrit over 16 weeks | 8 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Worsened Pcrit over 16 weeks | 2 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Improved SA-SDQ score over 16 weeks | 8 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Unchanged SA-SDQ score over 16 weeks | 8 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Worsened SA-SDQ score over 16 weeks | 2 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Improved Anterior tongue strength over 16 weeks | 8 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Unchanged Anterior tongue strength over 16 week | 8 | participants | |
| Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. | FP 220 mcg 2 Puffs BID | Worsened Anterior tongue strength over 16 week | 2 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FP 220 mcg 2 Puffs BID | 36 | |
| Overall Study | FP MDI 1,760 mcg/Day (16 Weeks) | FP 220 mcg 2 Puffs BID | 18 | |
| Overall Study | FP MDI 880 mcg/Day (2 Weeks) | FP 220 mcg 2 Puffs BID | 18 | |
| Overall Study | FP MDI as Indicated (2 Weeks) | FP 220 mcg 2 Puffs BID | 18 | |
| Overall Study | COMPLETED | FP 220 mcg 2 Puffs BID | 18 | |
| Overall Study | NOT COMPLETED | FP 220 mcg 2 Puffs BID | 18 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FP 220 mcg 2 Puffs BID | ||
| Total, other adverse events | FP 220 mcg 2 Puffs BID | 0 | 18 |
| Total, serious adverse events | FP 220 mcg 2 Puffs BID | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10HL074212 | Treatment of Severe Persistent Asthma | LEMANSKE, ROBERT F | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2003 to 2007 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01184118
GET https://conductscience.org/api/trials/v1/NCT01184118/registered