Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: tiotropium; Device: Handihaler; Device: Respimat

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Crete

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 3, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: February 12, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; sleep quality; sleeping oxygen saturation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: COPDTIOT100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No