Small Airways Disease in Asymptomatic and Symptomatic Sub... | NCT01549483

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

NCT01549483

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Jan 16, 2015Estimated

Enrollment

45Estimated

Phase

Not provided

Conditions

Asthma
Airway Hyperresponsiveness

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

May 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Mar 6, 2012

First Submission Date that Met QC Criteria

Mar 8, 2012

First Posted Date

Mar 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2015

Last Update Posted Date

Jan 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asthma		asthmatic subjects
Asymptomatic AHR		Asymptomatic subjects with airway hyperresponsiveness
Control		Healthy controls, without airway hyperresponsiveness

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
mRNA expression in nasal epithelium

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Out-patient clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maarten Van den Berge, M.D., PhD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen	Provincie Groningen	9700 RB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D012130	Respiratory Hypersensitivity

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided