Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331940
• Other study ID #: COPDTIOT100
• Status: Completed
• Phase: N/A
• First received: January 3, 2015
• Last updated: January 6, 2015
• Start date: March 2010
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Device:
• Handihaler
Inhalation via the HandiHaler once daily
• Respimat
Inhalation via the Respimat once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on sleeping oxygen saturation		6 months after treatment initiation	No
Primary	Changes on sleep quality		6 months after treatment initiation	No
Secondary	Change in sleepiness		6 months after treatment initiation	No
Secondary	Change in hospitalization rate		6 months after treatment initiation	No