Different End Points for Bronchial Hyperactivity (BHR) Tests.

Bronchial Hyperreactivity Clinical Trial

Official title:

Different End Points for Bronchial Hyperactivity (BHR) Tests, What Comes First?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654588
• Other study ID #: AD-S
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: December 10, 2014
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and quantify its severity.In older children and adults, BCT is done using spirometry to measure the value of 20% fall in FEV1 as an indicator for positive reactivity.

However, in young children and infants that cannot perform spirometry, other measurements are used as indicators for BHR. Traditionally, in these populations, appearance of wheezing on auscultation is used as the indicator for BHR. More recently, other measures like 50% increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible options to determine positive BHR. Nevertheless, as these measurements probably measure different parameters they could vary in time of appearance.

The investigators also noted that in older children who perform spirometry, the order of appearance of these different physiologic measures is not constant.

Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do not all appear at the same time and not in the same order of events.

Some children are noted to have a decrease in FEV1 without wheezing - those children can be difficult to diagnose as asthmatics in the primary care setting where asthma is being diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who do not wheeze are difficult to diagnose and therefore, are not getting the appropriate treatment.

Nevertheless, the data in current literature is very scant or not existing regarding these issues. Thus the investigators designed a study to prospectively try to answer the questions: do clinically significant differences exist in the concentration of the metacholine and / or adenosine at the time time of appearances of these parameters, what comes first, and if so, how does it affect the diagnosis and the severity assessment of HRA in different age groups?

Description:

Bronchial challenge tests (BCT) are being used to diagnose bronchial hyperactivity (BHR) and quantify its severity.

In older children and adults, BCT is done using spirometry to measure the value of 20% fall in FEV1 as an indicator for positive reactivity. However, in young children and infants that cannot perform spirometry, other measurements are used as indicators for BHR. Traditionally, in these populations, appearance of wheezing on auscultation is used as the indicator for BHR. More recently, other measures like 50% increase in respiratory rate or 5% decreases in oxygen saturation are mentioned as possible options to determine positive BHR. Nevertheless, as these measurements probably measure different parameters they could vary in time of appearance.

The investigators also noted that in older children who perform spirometry, the order of appearance of these different physiologic measures is not constant.

Decrease in O2 saturation, appearance of wheezing and increase in respiratory rate (RR) do not all appear at the same time and not in the same order of events.

Some children are noted to have a decrease in FEV1 without wheezing - those children can be difficult to diagnose as asthmatics in the primary care setting where asthma is being diagnosed on clinical grounds alone: wheezing and response to bronchodilators. Children who do not wheeze are difficult to diagnose and therefore, are not getting the appropriate treatment.

Nevertheless, the data in current literature is very scant or not existing regarding these issues. Thus the investigators designed a study to prospectively try to answer the questions: do clinically significant differences exist in the time of appearances of these parameters and if so, how does it affect the diagnosis and the severity assessment of HRA in different age groups? in this study we measure the metacholine and / or adenosine concentration at the time when the following parameters appear (what comes first): 20% fall in FEV1, 5% fall in oxygen saturation, 50% rise in respiratory rate, wheezing heard by the investigators using stethoscope.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Patients referred for HRA trigger testing

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchial Hyperreactivity

Locations

Country	Name	City	State
Israel	The Edith Wlofson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Which of the outcome ends points measures comes first in the diagnosis of bronchial hypersensitiveness.	Increasing concentrations of Metacholine or adenosine inhalations are given until there are 20% fall in FEV1 and / or 5% decrease in saturation and / or 50% increase in RR. The concentrations on which these outcomes occur are measured.	On which metacholine and / or adenosine increasing concentrations, there are 20% fall in FEV1 and / or 5% decrease in saturation and / or 50% increase in RR. Which comes first. Time frame: each BHR tests last up to two hours.	No
Secondary	Age influence on which comes first outcomes.	Age in years and months will be recorded. Age influence on the distribution of the main outcome - which comes first - will be calculated.	The time frame of the study: four years.	No