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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01549483

Acronym

ABHR

Enrollment

Registered

2012-03-09

Start date

2012-05-31

Completion date

2013-06-30

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Hyperresponsiveness, Asthma

Keywords

asthma, airway hyperresponsiveness, asymptomatic airway hyperresponsiveness, small airways

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Small airway parameters	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)
mRNA expression in nasal epithelium	visit 2	—
Peripheral airway resistance measured during provocation test	visit 2	Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine

Countries

Netherlands

Outcome results