Does extra fine HFA-BDP suppress small airways inflammation in COPD? - PAW002

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2008-005909-19-GB
• Lead Sponsor: The University of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-07
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Male or female >40 years old.
2) Post bronchodilator FEV1/FVC ratio of <0.7 and FEV1<80% predicted
3) Smoking history of =15 pack years
4) Small airways inflammation, characterised by elevated CANO (>3ppb).
5) Ability to comply with the requirements of the protocol.
6) Ability to give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Oral steroid use or exacerbation within 6 weeks. Greater than 2 exacerbations requiring treatment in the previous 6 months.
2) Requirement for domiciliary oxygen.
3) Diagnosis of asthma.
4) Significant concomitant respiratory disease including bronchiectasis, ABPA, cystic fibrosis or cor pulmonale.
5) Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol.
6) Any significantly abnormal laboratory result as deemed by the investigators.
Use of oral corticosteroids within the last 2 months.
7) Pregnancy, planned pregnancy or lactation.
8) Known or suspected contra-indication to any of the IMPs.
9) Concomitant use of medicines (prescribed, over-the counter or herbal) that may interfere with the trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish whether extra-fine particle steroid inhalers can suppress the small airways inflammation that is observed in COPD.;Secondary Objective: To observe any concomitant changes in respiratory function (spirometry, IOS, body plethysmography), symptoms (SGRQ), systemic inflammation (FBC, SPD, CRP, hsCRP, IL-6 and TNFa) and safety outcomes (glucose, over night urinary cortisol/creatinine ratio and 8am cortisol).;Primary end point(s): Suppression of alveolar nitric oxide (CANO), used as a surrogate of small airways inflammation.