Clinical trial NCT01522092: Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Official title: The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Anxiety
COPD
Keywords: Exacerbations
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2012-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: exacerbation rate
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Hospital Anxiety and depression scale (HADS)
timeFrame: 12 months
measure: General anxiety disorder(GAD-7)
timeFrame: 12 months
measure: Modified Medical Research Council (MMRC) dyspnoea scale
timeFrame: 12 month
measure: BODE index
timeFrame: 12 months
measure: Health related utilisation
timeFrame: 12 months
measure: Spirometry
timeFrame: 12 months
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital
state: East Yorkshire
Study officials:
affiliation: Hull University Teaching Hospitals NHS Trust
name: Alyn H Morice, Professor
role: PRINCIPAL_INVESTIGATOR
References: