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OpenTrials
Completed

NCT Number: NCT00327353

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Gauting, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

formoterol (TURBOHALER)

Drug

Salmeterol (DISKUS)

Drug

Other names: formoterol (TURBOHALER)

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2004
First posted
May 18, 2006
Registry last updated
May 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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