Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

NCT01522092 | Withdrawn Phase 3

• 2 other identifiers: Escit1607102010-022038-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; COPD

Keywords

Exacerbations

Outcome Measures

Primary Outcomes (1)

• exacerbation rate

  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.

  12 months

Secondary Outcomes (7)

• Quality of life

  12 months

• Hospital Anxiety and depression scale (HADS)

  12 months

• General anxiety disorder(GAD-7)

  12 months

• Modified Medical Research Council (MMRC) dyspnoea scale

  12 month

• BODE index

  12 months

Study Arms (1)

escitalopram

EXPERIMENTAL

escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months

Drug: escitalopram

Interventions

escitalopram DRUG

5mg-20mg, tablet, od, 12 months

Also known as: Cipralex

escitalopram

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders; Pulmonary Disease, Chronic Obstructive

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Mental Disorders; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Alyn H Morice, Professor

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Respiratory Medicine

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

GB (1)