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

Asthma Clinical Trial

— ABHR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549483
• Other study ID #: ABHR001
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: January 15, 2015
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Airway Hyperresponsiveness
• Asthma
• Pulmonary Disease, Chronic Obstructive
• Respiratory Hypersensitivity

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Small airway parameters	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)	visit 1	No
Secondary	mRNA expression in nasal epithelium		visit 2	No
Secondary	Peripheral airway resistance measured during provocation test	Resistance at 5 Hz (R5) during a bronchial provocation test with methacholine	visit 2	No