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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005909-19-GB

Enrollment

Registered

2009-01-07

Start date

2009-01-29

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD

Interventions

Trade Name: Qvar Easi-breathe 100mcg/actuation Product Name: Qvar Easibreathe 100mcg/actuation Product Code: PL 00530/0743 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: BECLOME

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female >40 years old. 2) Post bronchodilator FEV1/FVC ratio of 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026