Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
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|ClinicalTrials.gov Identifier: NCT01522092|
Recruitment Status : Withdrawn (Study was not given ethical approval- a alternative protocol required)
First Posted : January 31, 2012
Last Update Posted : March 29, 2017
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 or disease||Intervention/treatment||Phase|
|Anxiety COPD||Drug: escitalopram||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD|
escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months
5mg-20mg, tablet, od, 12 months
Other Name: Cipralex
- exacerbation rate [ Time Frame: 12 months ]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.
- Quality of life [ Time Frame: 12 months ]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 ]Change in HADS score at 3, 9, and 12 months from baseline
- General anxiety disorder(GAD-7) [ Time Frame: 12 months ]Change in GAD-7 score at 3,9 and 12 months from baseline
- Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: 12 month ]Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
- BODE index [ Time Frame: 12 months ]Change in BODE index at 3, 9 and 12months from baseline
- Health related utilisation [ Time Frame: 12 months ]Number of health related utilisations from baseline to 3, 9 and 12 months
- Spirometry [ Time Frame: 12 months ]Change in Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522092
|Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital|
|Cottingham, East Yorkshire, United Kingdom, HU16 5JQ|
|Principal Investigator:||Alyn H Morice, Professor||Hull and East Yorkshire Hospitals NHS Trust|