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Protocol - Bronchodilator Responsiveness (BDR)

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Protocol Name from Source:

COPDGene Study Clinical Center Manual of Procedures

Availability:

Publicly available

Description:

A series of spirometry maneuvers is performed to obtain acceptable and reproducible results. An inhaled bronchodilator medication is administered, and a second series of spirometry maneuvers is performed.

Protocol:

Bronchodilator Responsiveness Testing

1. Pre-Bronchodilator Spirometry

After instructing the participant about the procedure for spirometry testing, proceed with the actual testing (Pre-bronchodilator) using a spirometer which meets American Thoracic Society/European Respiratory Society guidelines. A successful test session is defined as at least three acceptable maneuvers, with the two best forced expiratory volume in 1 second (FEV1) values and the two best forced vital capacity (FVC) values from these maneuvers within 150 milliliters of each other.

2. Bronchodilator Administration

After at least 3 acceptable and 2 reproducible maneuvers (as defined above) are obtained, administer two puffs (180 mcg) of inhaled bronchodilator (albuterol), a short-acting beta-agonist, from a metered-dose inhaler to the participant using a spacer. A large-volume spacer, such as the Aerochamber®, should be used. A timer should be set up to sound 15 minutes after the last administered puff of bronchodilator.

3. Post-bronchodilator Maneuver

The post-bronchodilator (post-BD) maneuver can start any time after the 15-minute wait. The same criteria of at least 3 acceptable and 2 reproducible maneuvers should be followed. It is not critical that the post-BD maneuver be done immediately at 15 minutes, but rather that it is done at least 15 minutes but not more than 40 minutes after the last administered puff of bronchodilator.

Acceptable and Reproducible Maneuvers

For the purpose of spirometry testing, "acceptable" is defined as a maneuver that is free from error. "Reproducible" is defined as being without excessive variability between maneuvers. The following are some errors that can be seen or calculated from a forced expiratory maneuver and that can affect acceptability: hesitation or false starts, cough, variable effort, glottis closure, early termination, and leaks.

Three acceptable maneuvers are needed to determine reproducibility. The two highest values for FVC and FEV1 taken from acceptable forced expiratory maneuvers must show minimal variability (preferably within 150 milliliters of the second highest FVC or FEV1). It is also important to inspect the volume-time curves to determine if the shapes of the curves are reproducible.

The American Thoracic Society defines FEV1 and FVC as the best measurements from acceptable and reproducible maneuvers. It is not necessary that they all come from the same maneuver. The FEV1/FVC and FEV1/FEV6 (forced expiratory volume in six seconds) ratios are computed as the ratio of the individual measurements. When errors occur, review common errors with the subject before proceeding with additional maneuvers.

Ask the participant to watch the technician perform the FVC maneuver again. The technician should demonstrate the correct placement of the mouthpiece, emphasize the maximum depth of inhalation, and then blast out the air. If the participant tries again and the reproducibility criteria are not met, the technician should continue administering the test as needed (up to a total of eight maneuvers), assuming that the subject is able to continue.

Some participants will never be able to provide three acceptable efforts, and having two reproducible maneuvers is okay. The goal is to meet the acceptability and reproducibility criteria, but these are not absolute requirements for data to be used. Previous studies have shown that inability to perform reproducible spirometry, even with good coaching, is an important risk factor in predicting future health.

Contraindications

Spirometry testing with bronchodilator responsiveness should not be done if the subject has or reports any of the following:

• chest or abdominal surgery in the past three months

• a heart attack in the last three months

• detached retina or eye surgery in the past three months

• hospitalization for any other heart problem in the past month

• a resting pulse rate more than 120 beats/minute (participant should be sitting for at least 5 minutes prior to pulse rate determination)

4. Calculation of bronchodilator responsiveness: There are several ways to calculate bronchodilator responsiveness. The most commonly used methods include:

a) Percent of Baseline FEV1:

(Post-BD FEV1 Pre-BD FEV1)*100/(Pre-BD FEV1)

b) Percent of Predicted FEV1:

(Post-BD FEV1 Pre-BD FEV1)*100/(Predicted FEV1)

c) Absolute Volume:

(Post-BD FEV1 Pre-BD FEV1)

Aerochamber® is a registered trademark for Forest Pharmaceuticals, Inc.

Personnel and Training Required

Technician must be trained in performing spirometry and in administering bronchodilator medication.

Equipment Needs

Spirometer

Bronchodilator medication

Large-volume spacer

Timer

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualYes
Major equipmentYes
Specialized requirements for biospecimen collectionNo
Specialized trainingYes

Mode of Administration

Self-administered

Life Stage:

Child, Adolescent, Adult

Specific Instructions:

The Spirometry measure, also found in the Toolkit, should be followed for Step 1 of the Bronchodilator Responsiveness (BDR) testing process.

Research Domain Information

Release Date:

January 29, 2010

Definition

This measure assesses an individual’s change in pulmonary function in response to inhaled bronchodilator medications.

Purpose

To assess bronchial hyper-responsiveness, which is often seen in asthma and chronic obstructive pulmonary disease.

Selection Rationale

This protocol was selected from the COPDGene Study. This protocol is well-documented. Similar protocols have been used in many other studies. The protocol includes reliable instructions.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Bronchodilator Response Text2970280CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Resp bronchodil respons proto62615-0LOINC

Process and Review

[link[phenx.org/node/118|Expert Review Panel #6]] (ERP 6) reviewed the measures in the Respiratory domain.

Guidance from ERP 6 includes:

• No significant changes to measure

Back-compatible: no changes to Data Dictionary.

Source

US Department of Health and Human Services, National Institutes of Health, COPDGene Study, Manual of Procedures, Version 5.0 June 15, 2009. Refer to Clinical Center Manual of Procedures.

General References

Miller, M. R., Hankinson, J., Brusasco, V., Burgos, F., Casaburi, R., Coates, A., ... Wanger, J. (2005). Standardisation of spirometry. Series "ATS/ERS task force: Standardisation of lung function testing." European Respiratory Journal, 26(2), 319-338.

Protocol ID:

90301

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX090301_Pulse_RatePX090301010000Pulse Rate4Variable Mapping
PX090301_Spirometry_ContraindicatedPX090301020000Spirometry Contraindicated4N/A
PX090301_Reason_For_ContraindicationPX090301030000Reason for Contraindication4N/A
PX090301_Pre_Bronchodilator_FEV1PX090301040000Pre-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 14N/A
PX090301_Pre_Bronchodilator_FEV2PX090301050000Pre-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 24N/A
PX090301_Pre_Bronchodilator_FEV3PX090301060000Pre-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 34N/A
PX090301_Pre_Bronchodilator_FVC1PX090301070000Pre-Bronchodilator Forced Vital Capacity (FVC) 14N/A
PX090301_Pre_Bronchodilator_FVC2PX090301080000Pre-Bronchodilator Forced Vital Capacity (FVC) 24N/A
PX090301_Pre_Bronchodilator_FVC3PX090301090000Pre-Bronchodilator Forced Vital Capacity (FVC) 34N/A
PX090301_Post_Bronchodilator_FEV1PX090301100000Post-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 14N/A
PX090301_Post_Bronchodilator_FEV2PX090301110000Post-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 24N/A
PX090301_Post_Bronchodilator_FEV3PX090301120000Post-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 34N/A
PX090301_Post_Bronchodilator_FVC1PX090301130000Post-Bronchodilator Forced Vital Capacity (FVC) 14N/A
PX090301_Post_Bronchodilator_FVC2PX090301140000Post-Bronchodilator Forced Vital Capacity (FVC) 24N/A
PX090301_Post_Bronchodilator_FVC3PX090301150000Post-Bronchodilator Forced Vital Capacity (FVC) 34N/A
PX090301_Percent_Baseline_FEVPX090301160000Percent of Baseline Forced Expiratory Volume in 1 second4N/A
PX090301_Pre_Bronchodilator_FEVPX090301160100Pre-Bronchodilator Forced Expiratory Volume (FEV1) 4N/A
PX090301_Percent_Predicted_FEVPX090301170000Percent of Predicted Forced Expiratory Volume in 1 second4Variable Mapping
PX090301_Pre_Bronchodilator_FVCPX090301170100Pre-Bronchodilator Forced Vital Capacity (FVC) 4N/A
PX090301_Absolute_VolumePX090301180000Absolute Volume4N/A
PX090301_Post_Bronchodilator_FEVPX090301180100Post-Bronchodilator Forced Expiratory Volume (FEV1) 4N/A
PX090301_Post_Bronchodilator_FVCPX090301190000Post-Bronchodilator Forced Vital Capacity (FVC) 4N/A