Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

NCT ID: NCT02331940

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Handihaler

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

Group Type: ACTIVE_COMPARATOR

tiotropium

Intervention Type: DRUG

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.

Handihaler

Intervention Type: DEVICE

Inhalation via the HandiHaler once daily

Respimat

Tiotropium was delivered via the Respimat® Soft Mist Inhaler,

Group Type: ACTIVE_COMPARATOR

tiotropium

Intervention Type: DRUG

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.

Respimat

Intervention Type: DEVICE

Inhalation via the Respimat once daily

Interventions

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.

Intervention Type: DRUG

Handihaler

Inhalation via the HandiHaler once daily

Intervention Type: DEVICE

Respimat

Inhalation via the Respimat once daily

Intervention Type: DEVICE

Other Intervention Names

Spiriva

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophia E Schiza, MD, PhD

Role: STUDY_CHAIR

University of Crete

Other Identifiers

COPDTIOT100

Identifier Type: -

Identifier Source: org_study_id