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Determining the Optimal Adenosine Provocation Test (impact)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 22, 2012
First Posted Date  ICMJE June 4, 2012
Last Update Posted Date July 11, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
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 provocationtest after each provocative step.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determining the Optimal Adenosine Provocation Test
Official Title  ICMJE Determining the Optimal Dry Powder Adenosine Provocation Test to Assess Small Airways Disease
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.

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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Asthma
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Other: Bronchial provocation test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2012)
10
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01610921
Other Study ID Numbers  ICMJE NL 37702.042.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party E. van der Wiel, University Medical Center Groningen
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE Chiesi Farmaceutici S.p.A.
Investigators  ICMJE
Study Chair: Nick ten Hacken, MD, Phd University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP