Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

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.

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.