NCT01610921

Determining the Optimal Adenosine Provocation Test

Determining the Optimal Dry Powder Adenosine Provocation Test to Assess Small Airways Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial tree including the small airways (\<2mm). Since the introduction of the solution hydrofluoroalkane (HFA) technology it is possible to generate medication with small particles of approximately 1-2 μm, and therefore to reach the small airways. However, at this moment the investigators have no reliable instruments to identify the asthmatic subjects who particularly benefit from treatment with inhaled small particles. Recently the investigators research group investigated whether provocation with small and large particles AMP is able to identify responders and non-responders to treatment with small and large particles of inhaled corticosteroids. This provocation technique gave promising results but needs further optimization. The aim of this study is to determine the optimal particle size of dry powder adenosine to assess small airway involvement in asthma. Secondary, to provide insight in the associations between the standard test, executed with nebulized AMP, and the new test, executed with dry powder Adenosine.

Detailed description

This is a cross-over study. The study population consists of 10 non-smoking asthma patients in the age of 18-65 years who have a PC20 metacholine value ≤4.9mg/ml. Participating subjects perform 6 provocation tests in randomized order: one test with nebulized methacholine, one test with nebulized AMP, four times dry powder adenosine provocation test. (small particles with inhaled with a slow flow, small particles inhaled with a fast flow, large particles inhaled with a slow flow, large particles inhaled with a fast flow)

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Bronchial provocation test	Provocation tests with adenosine dry powder and nebulized AMP (adenosine-5'monophosphate). The AMP provocation test is a standard test and consists of 14 doubling concentrations in a range of 0.04mg/ml to 320mg/ml. The aerosols will be inhaled during tidal breathing for 2 minutes. The dry powder adenosine also consists of 14 doubling steps with doses in a range of 0.01mg to 20mg.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-10-01
• Completion: 2014-05-01
• First posted: 2012-06-04
• Last updated: 2014-07-11

Locations

2 sites across 1 country: Netherlands