Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245661
• Other study ID #: LTC-346/050905/Stege
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2005
• Last updated: October 31, 2007
• Start date: October 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2007
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Temazepam

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transcutaneous PCO2
Primary	transcutaneous PO2
Primary	Oxygen saturation
Secondary	Respiratory Disturbance Index
Secondary	Desaturation Index
Secondary	MSLT
Secondary	arterial PO2
Secondary	arterial PCO2
Secondary	Hypercapnic Ventilatory Response
Secondary	total sleeping time
Secondary	sleep latency
Secondary	percentage REM- and nREM-sleep of total sleep time
Secondary	number of arousals
Secondary	number of apneas during sleep
Secondary	number of hypopneas during sleep
Secondary	Epworth Sleeping Score
Secondary	Dyspnea Visual Analog Score

External Links

•   sponsor's web site