Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: tiotropium; Device: Handihaler; Device: Respimat

• Registration Number: NCT02331940
• Lead Sponsor: University of Crete

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2013-12
• Study Completion: 2014-09
• Study First Submitted: 2015-01-03
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Results First Submitted: 2016-05-10
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-12
• Last Update Submitted: 2017-02-12
• Results First Posted: 2017-03-30
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handihaler	Handihaler	Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
Respimat	tiotropium	Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
Respimat	Respimat	Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
Handihaler	tiotropium	Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler

Primary Outcome Measures

Name	Time	Method
Sleep Quality	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.
Sleeping Oxygen Saturation	6 months after treatment initiation	Mean sleeping oxygen saturation (%)

Secondary Outcome Measures

Name	Time	Method
Sleepiness	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)
Hospitalization Rate	6 months after treatment initiation	Number of patients needed hospitalization