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

NCT ID: NCT01549483

Last Updated: 2015-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Airway Hyperresponsiveness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Asthma

asthmatic subjects

No interventions assigned to this group

Asymptomatic AHR

Asymptomatic subjects with airway hyperresponsiveness

No interventions assigned to this group

Control

Healthy controls, without airway hyperresponsiveness

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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.


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Maarten van den Berge

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarten Van den Berge, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ABHR001

Identifier Type: -

Identifier Source: org_study_id

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