Chronic Obstructive Pulmonary DiseaseNCT02331940

Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

A study testing tiotropium, Handihaler and Respimat in people with Chronic Obstructive Pulmonary Disease, run by University of Crete.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: tiotropium, Handihaler and Respimat
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: Mar 2010to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 28Show fewer

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.

About this study

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

Read the 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
Being tested: tiotropium, Handihaler, Respimat
Keywords: Chronic obstructive pulmonary disease, sleeping oxygen saturation, sleep quality
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tiotropiumDrug
Also called Spiriva
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.
HandihalerDevice
Inhalation via the HandiHaler once daily
RespimatDevice
Inhalation via the Respimat once daily

Study groups in NCT02331940
Study group	Role	What they receive
Handihaler	Active comparator	Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler Receives: Drug: tiotropium; Device: Handihaler
Respimat	Active comparator	Tiotropium was delivered via the Respimat® Soft Mist Inhaler, Receives: Drug: tiotropium; Device: Respimat

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleeping Oxygen Saturation
Mean sleeping oxygen saturation (%)
Measured: 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.
Measured: 6 months after treatment initiation

Secondary outcomes (2)

Sleepiness
Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)
Measured: 6 months after treatment initiation
Hospitalization Rate
Number of patients needed hospitalization
Measured: 6 months after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Sep 2014

First posted6 Jan 2015 (estimated)
Study startMar 2010
Primary completionDec 2013
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02331940
Sponsor's protocol ID: COPDTIOT100
Status last verified: Feb 2017
First submitted: 3 Jan 2015
Last updated: 30 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tiotropium Respimat Soft Mist Inhaler Versus HandiHaler to Improve Sleeping Oxygen Saturation and Sleep Quality in COPD.
ClinicalTrials.gov ID: NCT02331940
Acronym / sponsor ID: COPDTIOT100
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease, sleeping oxygen saturation, sleep quality
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: University of CreteUniversity, hospital or other
Study start: Mar 2010
Primary completion: Dec 2013 (actual)
Study completion: Sep 2014 (actual)
First posted: 6 Jan 2015 (estimated)
Results: Posted 30 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Handihaler	Active comparator	Drug: tiotropium, Device: HandihalerTiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
Respimat	Active comparator	Drug: tiotropium, Device: RespimatTiotropium was delivered via the Respimat® Soft Mist Inhaler,

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tiotropiumAlso: SpirivaComparison 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.	Drug	Handihaler, Respimat
HandihalerInhalation via the HandiHaler once daily	Device	Handihaler
RespimatInhalation via the Respimat once daily	Device	Respimat

Primary outcome

Sleeping Oxygen Saturation
Time frame: 6 months after treatment initiation
Mean sleeping oxygen saturation (%)
Sleep Quality
Time frame: 6 months after treatment initiation
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.

2 secondary outcomes

Sleepiness
Time frame: 6 months after treatment initiation
Hospitalization Rate
Time frame: 6 months after treatment initiation

Results and safety

Results posted to the registry on 30 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Handihaler	100	93
Respimat	100	95

Primary outcome: Sleeping Oxygen Saturation

Time frame: 6 months after treatment initiation. Mean (Standard Deviation). Unit: percentage of Oxygen Saturation

Measure	Handihaler n = 93	Respimat n = 95
Value	94.4 (2.4)	94.4 (2.2)

Handihaler vs Respimat: p = 0.88, t-test, 1 sided

Primary outcome: Sleep Quality

Time frame: 6 months after treatment initiation. Mean (Standard Deviation). Unit: percentage of time

Measure	Handihaler n = 93	Respimat n = 95
sleep efficiency (%)	73.2 (11.8)	79.1 (13.4)
NREM (%TST)	87.3 (4.9)	85.3 (5.2)
REM (%TST)	12.7 (4.9)	14.7 (5.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Handihaler	0 of 93 (0%)	0 of 93 (0%)	Not reported
Respimat	0 of 95 (0%)	0 of 95 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sophia E Schiza, MD, PhD study chair

University of Crete

Questions about this trial

What is this clinical trial studying?

A study testing tiotropium, Handihaler and Respimat in people with Chronic Obstructive Pulmonary Disease, run by University of Crete.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleeping Oxygen Saturation (time frame: 6 months after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02331940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.