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

GlaxoSmithKline77 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

formoterol (TURBOHALER)DRUG

Salmeterol (DISKUS)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

GSK Investigational Site

Gauting, Bavaria, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Forced expiratory volume in 1 second (FEV1) under time curve 0.5-6 hours after inhalation of study medication

Secondary Outcomes

Airway resistances and peak FEV1 measured 0.5, 1, 2, 4 and 6 hours after inhalation of study drug

Data from ClinicalTrials.gov

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