Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

NCT02331940 | Completed Results

• 1 other identifier: COPDTIOT100
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; sleeping oxygen saturation; sleep quality

Outcome Measures

Primary Outcomes (2)

• Sleeping Oxygen Saturation

  Mean sleeping oxygen saturation (%)

  6 months after treatment initiation

• Sleep Quality

  Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100). NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time.

  6 months after treatment initiation

Secondary Outcomes (2)

• Sleepiness

  6 months after treatment initiation

• Hospitalization Rate

  6 months after treatment initiation

Study Arms (2)

Handihaler

ACTIVE COMPARATOR

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

Drug: tiotropium; Device: Handihaler

Respimat

ACTIVE COMPARATOR

Tiotropium was delivered via the Respimat® Soft Mist Inhaler,

Drug: tiotropium; Device: Respimat

Interventions

tiotropium 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.

Also known as: Spiriva

Handihaler; Respimat

Handihaler DEVICE

Inhalation via the HandiHaler once daily

Handihaler

Respimat DEVICE

Inhalation via the Respimat once daily

Respimat

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Crete: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: University of Crete

izolthi@gmail.com

2810394824

Study Officials

• Sophia E Schiza, MD, PhD

  University of Crete

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: January 3, 2015
• First Posted: January 6, 2015
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share