Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR) (ABHR)

January 15, 2015 updated by: Maarten van den Berge, University Medical Center Groningen

Differences in Small Airways Disease Between Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness

The purpose of this study is to study differences in small airways (<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Out-patient clinic

Description

Inclusion criteria for asymptomatic subjects with airway hyperresponsiveness (AHR) :

  • Age between 18 and 65 years.
  • Forced expiratory volume in one second (FEV1) > 80% predicted post bronchodilator.
  • Provocative concentration causing a 205 fall in FEV1 (PC20) methacholine <8 mg/ml.
  • No history of asthma or previous use of asthma medication.

Inclusion criteria for asymptomatic subjects without AHR :

  • Age between 18 and 65 years.
  • FEV1 > 80% predicted post bronchodilator.
  • PC20 methacholine >8 mg/ml.
  • No history of asthma or previous use of asthma medication.

Inclusion criteria for patients with asthma:

  • Age between 18 and 65 years.
  • FEV1 > 80% predicted.
  • PC20 methacholine ≤8 mg/ml.
  • Doctor's diagnosis of asthma.
  • No history of Chronic obstructive pulmonary disease (COPD).

Exclusion Criteria:

  • Use of inhaled or oral steroids, antihistamines, nedocromil, theophylline, leukotrien antagonists or long-acting beta-agonists for at least three weeks before the start of the study.
  • Any disease that may affect the outcome of the study as judged by the Investigator.
  • FEV1 <1.2 liter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Asthma
asthmatic subjects
Asymptomatic AHR
Asymptomatic subjects with airway hyperresponsiveness
Control
Healthy controls, without airway hyperresponsiveness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral airway resistance measured with impulse oscillometry (IOS)
Time Frame: visit 1
Difference between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R5-20).
visit 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small airway parameters
Time Frame: visit 1
Forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75), alveolar nitric oxide (NO), residual volume (RV), RV/total lung capacity (TLC)
visit 1
mRNA expression in nasal epithelium
Time Frame: visit 2
visit 2
Peripheral airway resistance measured during provocation test
Time Frame: visit 2
Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine
visit 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Maarten Van den Berge, M.D., PhD, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABHR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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