Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tiotropium Respimat Soft Mist Inhaler Versus HandiHaler to Improve Sleeping Oxygen Saturation and Sleep Quality in COPD.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: tiotropium
* Device: Handihaler
* Device: Respimat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged >=40 years old current or ex-smokers with a smoking history of at least 10 pack-years mild to moderate stable COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage I and II according to the 2010 GOLD guidelines (a post-bronchodilator forced expiratory volume in the first second (FEV1) ≥80% of predicted for stage I and 50% ≤ FEV1 < 80% of predicted for stage II, with a post-bronchodilator FEV1/forced vital capacity (FVC) ratio <0.70 at screening) waking arterial oxygen tension (PaO2) ≥60 mmHg Exclusion Criteria: refusal to participate respiratory tract infection within 4 weeks prior to screening COPD exacerbations requiring treatment with antibiotics and/or oral corticosteroids and/or hospitalization within 6 weeks prior to screening concomitant pulmonary diseases other than COPD asthma evidence of sleep apnea on baseline sleep studies obesity hypoventilation syndrome respiratory failure congestive heart failure a history of life-threatening arrhythmias cardiomyopathy long-QT syndrome or QTc >450 ms at screening diabetes long-term oxygen therapy symptomatic prostatic hyperplasia bladder-neck obstruction moderate/severe renal impairment urinary retention narrow-angle glaucoma family or personal history of mental illness drug or alcohol abuse severe cognitive impairment concurrent oncological diseases history of narcolepsy or restless legs syndrome known history of alpha-1 antitrypsin deficiency participation in the active phase of a supervised pulmonary rehabilitation program hypersensitivity to any of the test ingredients history of adverse reactions to inhaled anticholinergics.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Handihaler<br>Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler | Drug: tiotropium<br>* 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.<br>* Other names: Spiriva;Device: Handihaler<br>* Inhalation via the HandiHaler once daily<br>|
| Active Comparator: Respimat<br>Tiotropium was delivered via the Respimat® Soft Mist Inhaler, | Drug: tiotropium<br>* 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.<br>* Other names: Spiriva;Device: Respimat<br>* Inhalation via the Respimat once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Number of patients needed hospitalization | 6 months after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, sleeping oxygen saturation, sleep quality