Determining the Optimal Adenosine Provocation Test

NCT01610921 | Completed

• 1 other identifier: NL 37702.042.12
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

asthma; small airways disease; inflammation; provocation; adenosine

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

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

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

Study Arms (1)

bronchial provocationtest

EXPERIMENTAL

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

Interventions

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.

Also known as: bronchial challenge test, AMP test, adenosine bronchial provocation

bronchial provocationtest

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (2)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Nick ten Hacken, MD, Phd

  University Medical Center Groningen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: E. van der Wiel, MD

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: June 4, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: May 1, 2014
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

NL (2)