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The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.
Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension >60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Handihaler | Active Comparator | Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler |
|
| Respimat | Active Comparator | Tiotropium was delivered via the Respimat® Soft Mist Inhaler, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleeping Oxygen Saturation | Mean sleeping oxygen saturation (%) | 6 months after treatment initiation |
| Sleep Quality | 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. | 6 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Sleepiness | Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness) | 6 months after treatment initiation |
| Hospitalization Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophia E Schiza, MD, PhD | University of Crete | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleeping Oxygen Saturation | Mean sleeping oxygen saturation (%) | Posted | Mean | Standard Deviation | percentage of Oxygen Saturation | 6 months after treatment initiation |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | University of Crete | 2810394824 | 0030 | izolthi@gmail.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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|
| Handihaler | Device | Inhalation via the HandiHaler once daily |
|
| Respimat | Device | Inhalation via the Respimat once daily |
|
Number of patients needed hospitalization
| 6 months after treatment initiation |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Sleep Quality | 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. | Posted | Mean | Standard Deviation | percentage of time | 6 months after treatment initiation |
|
|
|
| Secondary | Sleepiness | Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness) | Posted | Mean | Standard Deviation | units on a scale | 6 months after treatment initiation |
|
|
|
| Secondary | Hospitalization Rate | Number of patients needed hospitalization | Posted | Number | participants | 6 months after treatment initiation |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | 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 | 0 | 95 | 0 | 95 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| REM (%TST) |
|