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

Completed

• Conditions: Asthma; Airway Hyperresponsiveness

• Registration Number: NCT01549483
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Study Start: 2012-05
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Peripheral airway resistance measured during provocation test	visit 2	Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine
mRNA expression in nasal epithelium	visit 2
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)

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands