Effect of Symbicort® on GR in sputum in COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-020440-35-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. Patients (n=35) with chronic obstructive pulmonary disease (COPD) with mild-to-moderate disease severity (GOLD 1 and 2 guidelines). The post-bronchodilator FEV1 will be used in the criteria to define GOLD severity. 2. Aged 38-80 years inclusive 3. FEV1 <15% reversibility (not % predicted) and/or an increase of <200 ml after inhaled ß2-agonists (400 µg salbutamol) 4. Patients will be allowed to use their current short-acting ß2-agonists (SABA) and long-acting ß2-agonists (LABA) and short-acting muscarinic-antagonist (SAMA) and long-acting muscarinic-antagonists (LAMA). However they should refrain from short-acting ß2-agonists (SABA) and short-acting muscarinic-antagonist (SAMA) for 6 hours before the study visit and for long-acting ß2-agonists (LABA) and long-acting muscarinic-antagonists (LAMA) at least 12 hours before the study visit, unless needed by the patient’s clinical condition. 5. Theophylline (an oral tablet bronchodilator) will be required to be stopped at least 3 days prior to start of Study Visit one, and patients will not be allowed this treatment during the study as it may affect the GR response and the bronchodilator (lung function, spirometry) responses. 6. Capable of giving informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study. 2. Patients who have a clinical diagnosis of Asthma, as decided by the Study Investigators, as this does not fulfil the diagnosis of chronic obstructive pulmonary disease (COPD). 3. Patients who have had a history of an upper or lower respiratory infection (including sinusitis) within 4 weeks prior to study entry, as this can affect the breathing response. 4. Patients who have received oral or parenteral steroids within 4 weeks prior to study entry, as this can affect the breathing response and signifies that their condition needs to be controlled better. 5. Patients who have been hospitalised for a COPD exacerbation within 1 month of study entry and/or has received antibiotics within 4 weeks of study entry, as this signifies that their condition needs to be controlled better. 6. Patients taking any regular medication that is contraindicated (as indicated in the British National Formularly) in those about to receive the study medications listed in this protocol; other than the oral contraceptive pill. 7. Any evidence of a positive pregnancy urine test for female volunteers or females who are pregnant or lactating or are likely to become pregnant during the trial. Women of child-bearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions (whihc will be directly enquired at the screening visit). 8. Patients who have a history of drug allergy which, in the opinion of the Unit Physician, contraindicates his/her participation in the study. 9. Patients with a known or suspected allergy to corticosteroids or any component of the formulations and/or suspected hypersensitivity to inhaled corticosteroid (this will be asked directly at the screening visit). 10. Patients who regularly, or on average, drink more than 21 units of alcohol (males) and 14 units of alcohol (female) per week (this will be asked directly at the screening visit).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The research question is whether inhaled drug treatments in combination (long-acting beta-2-agonists (LABA) together with inhaled corticosteroid (ICS)), that are routinely used for chronic obstructive pulmonary disease (COPD) patients can improve inflammation in the cells of the sputum/mucus from these patients compared to either drug component alone.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome measure is to investigate whether treatment with a single inhaled dose of Symbicort ®-800 or Symbicort ®-400 (a combination of a LABA - formoterol and an ICS – budesonide) will be reflected by changes in GR activation in sputum (on GR-GRE binding in sputum macrophages) that will be equal or superior to a single inhaled clinical dose of ICS alone (at double dose; that is, Pulmicort ®-800 = budesonide).