Skip to main content
OpenTrials
Completed

NCT Number: NCT01610921

Determining the Optimal Adenosine Provocation Test

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen, Groningen, Provincie Groningen, Netherlands

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A doctor's diagnosis of asthma
  • Age: 18-65 years
  • PC20 AMP < 320 mg/ml
  • Non-smoker
  • Steroid naive or steroids have been stopped 4 weeks before entry into the baseline period

Exclusion criteria

  • Recent exacerbation asthma (<2 months) or upper respiration tract infection (<2 weeks)
  • Severe airway obstruction at baseline, FEV1pred< 50% or < 1.2L
  • Diagnosis of COPD or any other pulmonary disease that could influence the study results as judged by the investigator
  • Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).

Treatment and study plan

Bronchial provocation test

Other

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.

Other names: bronchial challenge test, AMP test, adenosine bronchial provocation

Primary outcomes

  1. The small airway reaction to provocation with adenosine, reflected by the IOS parameter R5-R20

    Time frame: Small airway reaction is measured during each provocation test. The Visits will take place in a period of 6 weeks.

    The R5-R20 is measured with the IOS. This a method to determine the resistance of the small airways. The R5-R20 is measured during each provocation test after each provocative step.

Secondary outcomes

  1. The total airway reaction to provocation with adenosine, reflected by the decline in FEV1 (PD20/ PC20 values)

    Time frame: Lung function is measured during each provocation test. All visits take place in a period of 6 weeks.

    We want to compare the different PD20/PC20 values of the three dry powder adenosine provocation test and with the nebulized AMP provocation test. The lung function is measured after each provocative step to determine the point of 20% decline in FEV1. The provocation test is ended after the last step or is ended prematurely when there is a 20% fall of FEV1 compared to baseline

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

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

Acronym: impact

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 4, 2012
Registry last updated
Jul 11, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.