search
Back to results

Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tiotropium
Handihaler
Respimat
Sponsored by
University of Crete
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, sleeping oxygen saturation, sleep quality

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Handihaler

    Respimat

    Arm Description

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

    Tiotropium was delivered via the Respimat® Soft Mist Inhaler,

    Outcomes

    Primary Outcome Measures

    Sleeping Oxygen Saturation
    Mean sleeping oxygen saturation (%)
    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.

    Secondary Outcome Measures

    Sleepiness
    Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)
    Hospitalization Rate
    Number of patients needed hospitalization

    Full Information

    First Posted
    January 3, 2015
    Last Updated
    February 12, 2017
    Sponsor
    University of Crete
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02331940
    Brief Title
    Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients
    Official Title
    Tiotropium Respimat Soft Mist Inhaler Versus HandiHaler to Improve Sleeping Oxygen Saturation and Sleep Quality in COPD.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Crete

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    Chronic obstructive pulmonary disease, sleeping oxygen saturation, sleep quality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Handihaler
    Arm Type
    Active Comparator
    Arm Description
    Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
    Arm Title
    Respimat
    Arm Type
    Active Comparator
    Arm Description
    Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
    Intervention Type
    Drug
    Intervention Name(s)
    tiotropium
    Other Intervention Name(s)
    Spiriva
    Intervention Description
    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
    Device
    Intervention Name(s)
    Handihaler
    Intervention Description
    Inhalation via the HandiHaler once daily
    Intervention Type
    Device
    Intervention Name(s)
    Respimat
    Intervention Description
    Inhalation via the Respimat once daily
    Primary Outcome Measure Information:
    Title
    Sleeping Oxygen Saturation
    Description
    Mean sleeping oxygen saturation (%)
    Time Frame
    6 months after treatment initiation
    Title
    Sleep Quality
    Description
    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.
    Time Frame
    6 months after treatment initiation
    Secondary Outcome Measure Information:
    Title
    Sleepiness
    Description
    Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)
    Time Frame
    6 months after treatment initiation
    Title
    Hospitalization Rate
    Description
    Number of patients needed hospitalization
    Time Frame
    6 months after treatment initiation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophia E Schiza, MD, PhD
    Organizational Affiliation
    University of Crete
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

    We'll reach out to this number within 24 hrs