Chronic Obstructive Pulmonary DiseasePhase 3NCT00245661
Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease
A Phase 3 study testing Temazepam in people with Chronic Obstructive Pulmonary Disease, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease. The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Temazepam
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2005to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of COPD, GOLD 3 or 4
- having subjective sleeping problems
- longer latency to falling asleep
- frequent arousals
- excessive daytime sleepiness
- clinical stable health for minimally 6 weeks
Who cannot join
- usage of some sort of medication that influences sleep in any kind of way (like benzodiazepines, barbiturates, opiates, amfetamines) which can not be discontinued during the study period
- alcohol abuse
- hospitalisation 6 weeks or shorter before enrollment in the study
- hyperreactivity / allergy to benzodiazepines
- history of benzodiazepine-dependence
- myasthenia gravis
Show all 12Show fewer
- obstructive sleep apnea syndrome (OSAS)
- severe liver failure
- age under 18 years
- participation in another study less than 6 weeks before enrollment
- COPD exacerbation less than 6 weeks before enrollment
- usage of oxygen supplementation at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.
The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease.
The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.
Read the detailed description
Rationale: More than 50% of patients with chronic obstructive pulmonary disease (COPD) have sleep complaints characterised by longer latency to falling asleep, more frequent arousals and awakenings, generalised insomnia and/or excessive daytime sleepiness. Sleep disturbance seems to be more severe with advancing disease and substantially reduces patients' quality of life. The sleep complaints are due to dyspnea, chronic cough, sputum production, hypoxaemia and hypercapnia during the night. One of the available therapies for these patients is the prescription of hypnotics (like benzodiazepines). However, it is thought that in patients with COPD sleep medication may produce adverse respiratory effects due to suppression of the cerebral respiratory drive. In our practice, we never encounter any adverse respiratory effect of an hypnotic in patients with COPD. There have been several trials in COPD patients studying these potentially adverse effects. The results of these studies are inconsistent, relative older hypnotics are used and there are several methodological limitations. Furthermore, in none of these studies transcutaneous PCO2 or PO2 was monitored. Temazepam is nowadays the sedative of first choice in the medical treatment of sleep complaints.
Aim: primary: studying the effects of temazepam on the respiratory function during daytime and at night in patients with severe COPD. Secondary: studying the effects of temazepam on the sleep quality and sleep structure and on the objective and subjective sleepiness during daytime and at night in patients with COPD.
Study design: double blind, placebo-controlled, cross-over randomised clinical trial.
Treatment: 10 mg temazepam or placebo during seven consecutive nights.
Endpoints: Primary: difference in PtcCO2, PtcO2 and oxygen saturation during sleep after 1 week temazepam compared to placebo. Secondary: Respiratory Disturbance Index, Desaturation Index and Hypercapnic Ventilatory Response, percentage REM/nREM-sleep and total effective sleep time, Multiple Sleep Latency Test and the Epworth Sleeping Score.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Temazepam
- Keywords
- COPD, respiratory, sleep quality, temazepam, dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemazepamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
transcutaneous PCO2
transcutaneous PO2
Oxygen saturation
Secondary outcomes (14)
Respiratory Disturbance Index
Desaturation Index
MSLT
arterial PO2
arterial PCO2
Hypercapnic Ventilatory Response
total sleeping time
sleep latency
percentage REM- and nREM-sleep of total sleep time
number of arousals
number of apneas during sleep
number of hypopneas during sleep
Epworth Sleeping Score
Dyspnea Visual Analog Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startOct 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gerben Stege, MD, Principal investigator, Rijnstate HospitalPeter J de Bruijn, MD, Study director, Rijnstate HospitalRichard PN Dekhuijzen, Prof. PhD MD, Study director, UMC St. RadboudFrank JJ van den Elshout, PhD MD, Study director, Rijnstate HospitalYvonne F Heijdra, PhD MD, Study director, UMC St. RadboudMarjo JT van de Ven, PhD MD, Study director, Rijnstate HospitalPetra JE Vos, PhD MD, Study chair, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245661
- Sponsor's protocol ID
- LTC-346/050905/Stege
- Status last verified
- Oct 2007
- First submitted
- 27 Oct 2005
- Last updated
- 2 Nov 2007
- Results posted
- No
Publications
Stege G, Heijdra YF, van den Elshout FJ, van de Ven MJ, de Bruijn PJ, van Sorge AA, Dekhuijzen PN, Vos PJ. Temazepam 10mg does not affect breathing and gas exchange in patients with severe normocapnic COPD. Respir Med. 2010 Apr;104(4):518-24. doi: 10.1016/j.rmed.2009.10.022. Epub 2009 Nov 12.
PubMed 19910177
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT00245661
- Acronym / sponsor ID
- LTC-346/050905/Stege
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, respiratory, sleep quality, temazepam, dyspnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 28 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease.
The study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.
Detailed description
Rationale: More than 50% of patients with chronic obstructive pulmonary disease (COPD) have sleep complaints characterised by longer latency to falling asleep, more frequent arousals and awakenings, generalised insomnia and/or excessive daytime sleepiness. Sleep disturbance seems to be more severe with advancing disease and substantially reduces patients' quality of life. The sleep complaints are due to dyspnea, chronic cough, sputum production, hypoxaemia and hypercapnia during the night. One of the available therapies for these patients is the prescription of hypnotics (like benzodiazepines). However, it is thought that in patients with COPD sleep medication may produce adverse respiratory effects due to suppression of the cerebral respiratory drive. In our practice, we never encounter any adverse respiratory effect of an hypnotic in patients with COPD. There have been several trials in COPD patients studying these potentially adverse effects. The results of these studies are inconsistent, relative older hypnotics are used and there are several methodological limitations. Furthermore, in none of these studies transcutaneous PCO2 or PO2 was monitored. Temazepam is nowadays the sedative of first choice in the medical treatment of sleep complaints.
Aim: primary: studying the effects of temazepam on the respiratory function during daytime and at night in patients with severe COPD. Secondary: studying the effects of temazepam on the sleep quality and sleep structure and on the objective and subjective sleepiness during daytime and at night in patients with COPD.
Study design: double blind, placebo-controlled, cross-over randomised clinical trial.
Treatment: 10 mg temazepam or placebo during seven consecutive nights.
Endpoints: Primary: difference in PtcCO2, PtcO2 and oxygen saturation during sleep after 1 week temazepam compared to placebo. Secondary: Respiratory Disturbance Index, Desaturation Index and Hypercapnic Ventilatory Response, percentage REM/nREM-sleep and total effective sleep time, Multiple Sleep Latency Test and the Epworth Sleeping Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of COPD, GOLD 3 or 4
- having subjective sleeping problems
- clinical stable health for minimally 6 weeks
Key exclusion criteria (12 listed)
- usage of some sort of medication that influences sleep in any kind of way (like benzodiazepines, barbiturates, opiates, amfetamines) which can not be discontinued during the study period
- alcohol abuse
- hospitalisation 6 weeks or shorter before enrollment in the study
- hyperreactivity / allergy to benzodiazepines
- history of benzodiazepine-dependence
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 |
|---|---|---|
| Temazepam | Drug | – |
Primary outcome
transcutaneous PCO2
transcutaneous PO2
Oxygen saturation
14 secondary outcomes
Respiratory Disturbance Index
Desaturation Index
MSLT
arterial PO2
arterial PCO2
Hypercapnic Ventilatory Response
total sleeping time
sleep latency
percentage REM- and nREM-sleep of total sleep time
number of arousals
number of apneas during sleep
number of hypopneas during sleep
Epworth Sleeping Score
Dyspnea Visual Analog Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Derived from this study: PubMed 19910177Stege G, Heijdra YF, van den Elshout FJ, van de Ven MJ, de Bruijn PJ, van Sorge AA, Dekhuijzen PN, Vos PJ. Temazepam 10mg does not affect breathing and gas exchange in patients with severe normocapnic COPD. Respir Med. 2010 Apr;104(4):518-24. doi: 10.1016/j.rmed.2009.10.022. Epub 2009 Nov 12.
- sponsor's web siteLink provided by the sponsor.
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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.
Gerben Stege, MD principal investigator
Rijnstate Hospital
Peter J de Bruijn, MD study director
Rijnstate Hospital
Richard PN Dekhuijzen, Prof. PhD MD study director
UMC St. Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temazepam in people with Chronic Obstructive Pulmonary Disease, run by Rijnstate Hospital at 1 site in Netherlands.
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 6 inclusion and 12 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 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
transcutaneous PCO2. The study lists 3 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 NCT00245661, which also lists 1 linked publication.
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 2 Nov 2007.