Status:
COMPLETED
Acute Effects of a Flutter Device in COPD
Lead Sponsor:
Imperial College London
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of th...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible. This limitation is usually progressive and associated with an abnormal inflammatory re...
Eligibility Criteria
Inclusion
- \- patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) \<80% predicted, FEV1/FVC ratio \<70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) \>80% predicted), with or without sputum, will be included.
- The severity of COPD will be classified according to GOLD criteria:
- Stage I: mild FEV1/FVC\<0.70 and FEV1\>80% predicted; Stage II: moderate FEV1/FVC\<0.70 and 50\<FEV1\<80% predicted; Stage III: severe FEV1/FVC\<0.70 and 30\<FEV1\<50% predicted; Stage IV: very severe FEV1/FVC\<0.70 and FEV1\<30% or FEV1\<50% predicted plus chronic respiratory failure,
Exclusion
- Patients with:
- Upper respiratory tract infection within the previous 28 days
- Treatment with antibiotics within 4 weeks prior the study
- Acute dyspnoea or hemoptysis
- Chest pain or recent history of rib fracture or pneumothorax
- Acute cardiovascular events in the previous 3 months
- Any history or evidence of renal, gastrointestinal or hepatic disease
- Any history and evidence of neuropsychiatric disease
- Alcohol, drug abuse or any other condition associated with poor compliance
- Breast feeding
- Pregnancy
- Other complications that hinder the completion of the tests
- Unable to provide written informed consent
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01832961
Start Date
April 1 2013
End Date
December 1 2013
Last Update
February 27 2020
Active Locations (1)
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1
Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London
London, United Kingdom, SW3 6LY