Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

University of Crete

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Handihaler; Device: Respimat; Drug: tiotropium

Study type: Interventional

Funder types: Other

Identifiers

NCT02331940

COPDTIOT100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Handihaler

Active Comparator group

Description:

Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler

Treatment:

Drug: tiotropium

Device: Handihaler

Respimat

Active Comparator group

Description:

Tiotropium was delivered via the Respimat® Soft Mist Inhaler,

Treatment:

Device: Respimat

Drug: tiotropium