Determining the Optimal Adenosine Provocation Test

Asthma Clinical Trial

— impact  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610921
• Other study ID #: NL 37702.042.12
• Status: Completed
• Phase: N/A
• First received: May 22, 2012
• Last updated: July 10, 2014
• Start date: February 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The small airway reaction to provocation with adenosine, reflected by the IOS parameter R5-R20	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.	Small airway reaction is measured during each provocation test. The Visits will take place in a period of 6 weeks.	No
Secondary	The total airway reaction to provocation with adenosine, reflected by the decline in FEV1 (PD20/ PC20 values)	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	Lung function is measured during each provocation test. All visits take place in a period of 6 weeks.	Yes