Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.

Clinical Trial Description

About 30% of the adult population report sleep disturbance and 10% meet diagnostic criteria for chronic insomnia. While 20 -25% of these individuals have primary insomnia the vast majority have an additional condition such as chronic obstructive pulmonary disease. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia related conditions or diseases that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism and greater rates of accidents.

Ramelteon, is being developed as a sleep promoting agent based on agonism of melatonin receptor subtype 1 and 2. Ramelteon is marketed in the United States as Rozerem™ for the treatment of insomnia characterized by difficulty with sleep initiation.

Sleep problems are common in patients with chronic obstructive pulmonary disease. There is evidence that traditional hypnotics can cause adverse respiratory effects in insomniac populations with respiratory disorders, and so the safety and efficacy of new hypnotic agents must be ascertained in this group of patients.

This study will examine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease. Study participation is anticipated to be about 6 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00316992
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 4
Start date	April 2006
Completion date	November 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05102305` - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed	`NCT01867762` - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease	Phase 2
Recruiting	`NCT05562037` - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA	N/A
Terminated	`NCT04921332` - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD	N/A
Completed	`NCT03089515` - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust	N/A
Completed	`NCT02787863` - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology	Phase 4
Recruiting	`NCT05552833` - Pulmonary Adaptive Responses to HIIT in COPD	N/A
Recruiting	`NCT05835492` - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting	`NCT05631132` - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?	N/A
Completed	`NCT03244137` - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting	`NCT03282526` - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease	N/A
Completed	`NCT02546700` - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)	Phase 2
Withdrawn	`NCT04446637` - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD	Phase 3
Completed	`NCT04535986` - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD	Phase 3
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed	`NCT03256695` - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)	Phase 3
Completed	`NCT03295474` - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Withdrawn	`NCT04042168` - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)	Phase 4
Completed	`NCT03414541` - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease	Phase 2
Completed	`NCT02552160` - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy