Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma (PAW01)

University of Dundee

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Fluticasone; Drug: HFA-BDP; Drug: Seretide

Study type: Interventional

Funder types: Other

Identifiers

NCT00829257

PAW01

Eudract no: 2008-001811-40 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
• RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
• Informed consent and ability to perform exhaled nitric oxide assessment.
• Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.

Exclusion criteria

• Recent respiratory infection or oral steroid use.
• Pregnancy or lactation.
• Known or suspected contra-indication to any of the IMP's.
• CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Fine particle steroid inhaler

Experimental group

Description:

HFA-BDP plus Fluticasone/Salmeterol Combination

Treatment:

Drug: Seretide

Drug: HFA-BDP

Coarse Particle Inhaler

Active Comparator group

Description:

FP plus Fluticasone/Salmeterol combination

Treatment:

Drug: Seretide

Drug: Fluticasone