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

This study is not yet open for participant recruitment.

Verified March 2012 by University Medical Centre Groningen

Sponsor:

Information provided by (Responsible Party):

Maarten van den Berge, University Medical Centre Groningen

ClinicalTrials.gov Identifier:

NCT01549483

First received: March 6, 2012

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 6, 2012

Last Updated Date

March 8, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peripheral airway resistance measured with impulse oscillometry (IOS) [ Time Frame: visit 1 ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01549483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Small airway parameters [ Time Frame: visit 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
Peripheral airway resistance measured during provocation test [ Time Frame: visit 2 ] [ Designated as safety issue: No ]
Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Nasal epithelium brushes for mRNA expression

Sampling Method

Non-Probability Sample

Study Population

Out-patient clinic

Condition ^ICMJE

Asthma
Airway Hyperresponsiveness

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Maarten Van den Berge, M.D., PhD	+31503616161 ext 12357	m.van.den.berge@umcg.nl
Contact: Eef D. Telenga, M.D.	+31503616161 ext 19192	e.d.telenga@umcg.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01549483

Other Study ID Numbers ^ICMJE

ABHR001

Has Data Monitoring Committee

Responsible Party

Maarten van den Berge, University Medical Centre Groningen

Study Sponsor ^ICMJE

University Medical Centre Groningen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Maarten Van den Berge, M.D., PhD

University Medical Centre Groningen

Information Provided By

University Medical Centre Groningen

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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