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

NCT01549483 | Completed

• 1 other identifier: ABHR001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Airway Hyperresponsiveness

Keywords

asthma; airway hyperresponsiveness; asymptomatic airway hyperresponsiveness; small airways

Outcome Measures

Primary Outcomes (1)

• Peripheral airway resistance measured with impulse oscillometry (IOS)

  Difference between resistance at 5 Hz (R5) and resistance at 20 Hz (R20) (R5-20).

  visit 1

Secondary Outcomes (3)

• Small airway parameters

  visit 1

• mRNA expression in nasal epithelium

  visit 2

• Peripheral airway resistance measured during provocation test

  visit 2

Study Arms (3)

Asthma

asthmatic subjects

Asymptomatic AHR

Asymptomatic subjects with airway hyperresponsiveness

Control

Healthy controls, without airway hyperresponsiveness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patient clinic

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal epithelium brushes for mRNA expression

MeSH Terms

Conditions

Asthma; Respiratory Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Maarten Van den Berge, M.D., PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

NL (1)