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Trial record 3 of 248 for:    test AND provocation

Determining the Optimal Adenosine Provocation Test (impact)

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ClinicalTrials.gov Identifier: NCT01610921
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : July 11, 2014
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
E. van der Wiel, University Medical Center Groningen

Brief 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.


Condition or disease Intervention/treatment Phase
Asthma Other: Bronchial provocation test Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Determining the Optimal Dry Powder Adenosine Provocation Test to Assess Small Airways Disease
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: bronchial provocationtest
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: 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.
Other Names:
  • bronchial challenge test
  • AMP test
  • adenosine bronchial provocation




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610921


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Chiesi Farmaceutici S.p.A.
Investigators
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Study Chair: Nick ten Hacken, MD, Phd University Medical Center Groningen

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Responsible Party: E. van der Wiel, E. van der Wiel, MD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01610921     History of Changes
Other Study ID Numbers: NL 37702.042.12
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

Keywords provided by E. van der Wiel, University Medical Center Groningen:
asthma
small airways disease
inflammation
provocation
adenosine

Additional relevant MeSH terms:
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Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action