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

Single-Centre Randomised Open Crossover Study to Examine the Influence of Different Internal Resistances of Discus and Turbohaler Respectively on the Effects of Salmeterol and Formoterol in Asthmatic Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00327353

Enrollment

Registered

2006-05-18

Start date

2004-01-31

Completion date

Unknown

Last updated

2009-05-22

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

Conditions

Asthma

Keywords

Asthma, Salmeterol, Formoterol, Airway resistance

Brief summary

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

Interventions

DRUGformoterol (TURBOHALER)

DRUGSalmeterol (DISKUS)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026