Clinical trial NCT02331940: Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients
Official title: Tiotropium Respimat Soft Mist Inhaler Versus HandiHaler to Improve Sleeping Oxygen Saturation and Sleep Quality in COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
sleeping oxygen saturation
sleep quality
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleeping Oxygen Saturation
timeFrame: 6 months after treatment initiation
measure: Sleep Quality
timeFrame: 6 months after treatment initiation
Secondary outcomes:
measure: Sleepiness
timeFrame: 6 months after treatment initiation
measure: Hospitalization Rate
timeFrame: 6 months after treatment initiation
Other outcomes:
Locations:
Study officials:
affiliation: University of Crete
name: Sophia E Schiza, MD, PhD
role: STUDY_CHAIR
References: