Influence Of Different Airflow Resistances On Drug Effect Of 50μg Salmeterol And 6 μg Formoterol

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: formoterol (TURBOHALER); Drug: Salmeterol (DISKUS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327353

TURBOHALER Faktor

101182

Details and patient eligibility

About

Effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. Different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthma Reversibility >15% and 200 ml in total FEV1 <85% of normal

Exclusion criteria

• Smoking history >20 pack years Treatment with ICS >500μg Fluticasone or aquivalent in the last 4 weeks Asthma exacerbation in the last 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)