Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
This study is not yet open for participant recruitment.
Verified September 2012 by Hull and East Yorkshire Hospitals NHS Trust
Sponsor:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01522092
First received: January 27, 2012
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
Anxiety and depression are common in patients with severe chronic obstructive pulmonary disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear and indeed this may be the main cause for the for hospital admission. Patients prone to a tendency to experience and communicate somatic distress in response to psychosocial stress and to seek medical help for it are top of the "frequent flyer" league, costing the health care economy dearly. This is a particular problem in Hull with the high levels of smoking and urban deprivation combining to place the city at the bottom of the Department of Health COPD league tables.
Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus allowing the patient time to access the existing community based support services.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety COPD |
Drug: escitalopram |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD |
Resource links provided by NLM:
Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:
Primary Outcome Measures:
- exacerbation rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]comparison of the rate of COPD exacerbation in the year preceding treatment with that on escitalopram treatment in patients with COPD adjudged to have a significant element of anxiety.
Secondary Outcome Measures:
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire
- Hospital Anxiety and depression scale (HADS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in HADS score at 3, 9, and 12 months from baseline
- General anxiety disorder(GAD-7) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in GAD-7 score at 3,9 and 12 months from baseline
- Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: 12 month ] [ Designated as safety issue: No ]Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
- BODE index [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in BODE index at 3, 9 and 12months from baseline
- Health related utilisation [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of health related utilisations from baseline to 3, 9 and 12 months
- Spirometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]Change in FEV1, FVC and PEF measured at 3, 9 and 12 months from baseline
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: escitalopram
5mg-20mg, tablet, od, 12 months
Other Name: Cipralex
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male/females aged between 40-80 years.
- Previous diagnosis of COPD confirmed by the GOLD criteria.
- At least two previous admissions to hospital for acute exacerbation of COPD.
- Physician diagnosed anxiety
- At least Mild anxiety score on HADS and GAD-7
- On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
- Known history of cigarette smoking at least 10 pack yrs
- Willing and able to comply with study procedures
- Able to provide written informed consent to participate
Exclusion Criteria:
- Current or past diagnosis of asthma
- Long-term oxygen therapy
- Currently on treatment with anti-depressives
- Serious inter-current illness (eg lung cancer)
- One year survival considered unlikely
- Patients who have evidence of alcohol or drug abuse
- Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit
- Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
- Known or suspected hypersensitivity to escitalopram
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522092
Contacts
| Contact: Caroline E Wright, BSc | 01482 624067 ext 3782 | c.e.wright@hull.ac.uk |
| Contact: Jackie Mower, RGN | 01482 624009 | jackie.mower@hey.nhs.uk |
Locations
| United Kingdom | |
| Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital | Not yet recruiting |
| Cottingham, East Yorkshire, United Kingdom, HU16 5JQ | |
| Principal Investigator: Alyn H Morice, Professor | |
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
| Principal Investigator: | Alyn H Morice, Professor | Hull and East Yorkshire Hospitals NHS Trust |
More Information
No publications provided
| Responsible Party: | Prof A H Morice, professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01522092 History of Changes |
| Other Study ID Numbers: | Escit160710, 2010-022038-10 |
| Study First Received: | January 27, 2012 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
|
Exacerbations |
Additional relevant MeSH terms:
|
Anxiety Disorders Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Mental Disorders Respiratory Tract Diseases Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 19, 2013