Spacer Comparison In Adult Asthmatics

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: fluticasone propionate/salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369993

SAS104449

Details and patient eligibility

About

Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

Full description

A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC™ both in their washed and unwashed states in adult subjects with mild or intermittent asthma.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-smoking with a BMI of 19 - 30
• Diagnosed with mild or intermittent asthma and taking medication for it.

Exclusion criteria

• Taking oral corticosteroids or inhaled fluticasone propionate
• Have certain medical conditions or are not otherwise healthy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)