Trial Outcomes & Findings for DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations? (NCT NCT01184118)

NCT ID: NCT01184118

Last Updated: 2016-09-07

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2016-09-07

Participant Flow

Participant milestones

Measure	FP 220 mcg 2 Puffs BID The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
Overall Study STARTED	36
Overall Study FP MDI 1,760 mcg/Day (16 Weeks)	18
Overall Study FP MDI 880 mcg/Day (2 Weeks)	18
Overall Study FP MDI as Indicated (2 Weeks)	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	FP 220 mcg 2 Puffs BID The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
Overall Study Only asthma step 1 - screen fail	1
Overall Study No physiologic confirmation of asthma	8
Overall Study FEV1 <60% predicted	2
Overall Study Exclusionary medical condition	2
Overall Study Withdrawal by Subject	5

Baseline Characteristics

DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?

Baseline characteristics by cohort

Measure	FP 220 mcg 2 Puffs BID n=18 Participants The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care. FP 220 mcg 2 puffs BID: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25.9 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
BMI	26.8 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	FP 220 mcg 2 Puffs BID n=18 Participants The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment. 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. 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. Worsened Pcrit over 16 weeks	2 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	FP 220 mcg 2 Puffs BID n=18 Participants The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment. 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. 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. Worsened SA-SDQ score over 16 weeks	2 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	FP 220 mcg 2 Puffs BID n=18 Participants The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment. 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. 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. Worsened Anterior tongue strength over 16 week	2 participants

Adverse Events

FP 220 mcg 2 Puffs BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mihaela Teodorescu, MD

UW Madison

Phone: 608-256-1901

Email: mt3@medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place