Trial Outcomes & Findings for Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients (NCT NCT02331940)

NCT ID: NCT02331940

Last Updated: 2017-03-30

Results Overview

Mean sleeping oxygen saturation (%)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 6 months after treatment initiation
• Results posted on: 2017-03-30

Participant Flow

Participant milestones

Measure	Handihaler Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Handihaler: Inhalation via the HandiHaler once daily	Respimat Tiotropium was delivered via the Respimat® Soft Mist Inhaler, tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Respimat: Inhalation via the Respimat once daily
Overall Study STARTED	100	100
Overall Study COMPLETED	93	95
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Baseline characteristics by cohort

Measure	Handihaler n=93 Participants Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Handihaler: Inhalation via the HandiHaler once daily	Respimat n=95 Participants Tiotropium was delivered via the Respimat® Soft Mist Inhaler, tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Respimat: Inhalation via the Respimat once daily	Total n=188 Participants Total of all reporting groups
Age, Continuous	53.7 Years STANDARD_DEVIATION 11.3 • n=5 Participants	54.9 Years STANDARD_DEVIATION 11.8 • n=7 Participants	54.3 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	25 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	70 Participants n=7 Participants	133 Participants n=5 Participants
Region of Enrollment Greece	93 participants n=5 Participants	95 participants n=7 Participants	188 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after treatment initiation

Mean sleeping oxygen saturation (%)

Outcome measures

Measure	Handihaler n=93 Participants Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Handihaler: Inhalation via the HandiHaler once daily	Respimat n=95 Participants Tiotropium was delivered via the Respimat® Soft Mist Inhaler, tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Respimat: Inhalation via the Respimat once daily
Sleeping Oxygen Saturation	94.4 percentage of Oxygen Saturation Standard Deviation 2.4	94.4 percentage of Oxygen Saturation Standard Deviation 2.2

PRIMARY outcome

Timeframe: 6 months after treatment initiation

Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100).

NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time.

Outcome measures

Measure	Handihaler n=93 Participants Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Handihaler: Inhalation via the HandiHaler once daily	Respimat n=95 Participants Tiotropium was delivered via the Respimat® Soft Mist Inhaler, tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Respimat: Inhalation via the Respimat once daily
Sleep Quality sleep efficiency (%)	73.2 percentage of time Standard Deviation 11.8	79.1 percentage of time Standard Deviation 13.4
Sleep Quality NREM (%TST)	87.3 percentage of time Standard Deviation 4.9	85.3 percentage of time Standard Deviation 5.2
Sleep Quality REM (%TST)	12.7 percentage of time Standard Deviation 4.9	14.7 percentage of time Standard Deviation 5.2

SECONDARY outcome

Timeframe: 6 months after treatment initiation

Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)

Outcome measures

Measure	Handihaler n=93 Participants Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Handihaler: Inhalation via the HandiHaler once daily	Respimat n=95 Participants Tiotropium was delivered via the Respimat® Soft Mist Inhaler, tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Respimat: Inhalation via the Respimat once daily
Sleepiness	6.5 units on a scale Standard Deviation 5.9	6.1 units on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: 6 months after treatment initiation

Number of patients needed hospitalization

Outcome measures

Measure	Handihaler n=93 Participants Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Handihaler: Inhalation via the HandiHaler once daily	Respimat n=95 Participants Tiotropium was delivered via the Respimat® Soft Mist Inhaler, tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD. Respimat: Inhalation via the Respimat once daily
Hospitalization Rate	0 participants	0 participants

Adverse Events

Handihaler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Respimat

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

Director of Clinical Trials

University of Crete

Phone: 2810394824

Email: izolthi@gmail.com

Results disclosure agreements

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