Protocol - Bronchodilator Responsiveness (BDR)
Protocol Name from Source:
COPDGene Study Clinical Center Manual of Procedures
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.
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.
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.
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.
|Average time of greater than 15 minutes in an unaffected individual||Yes|
|Specialized requirements for biospecimen collection||No|
Mode of Administration
Child, Adolescent, Adult
The Spirometry measure, also found in the Toolkit, should be followed for Step 1 of the Bronchodilator Responsiveness (BDR) testing process.
January 29, 2010
This measure assesses an individual’s change in pulmonary function in response to inhaled bronchodilator medications.
To assess bronchial hyper-responsiveness, which is often seen in asthma and chronic obstructive pulmonary disease.
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.
|Common Data Elements (CDE)||Person Bronchodilator Response Text||2970280||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Resp bronchodil respons proto||62615-0||LOINC|
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.
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.
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.
|Variable Name||Variable ID||Variable Description||Version||dbGaP Mapping|
|PX090301_Pulse_Rate||PX090301010000||Pulse Rate||4||Variable Mapping|
|PX090301_Reason_For_Contraindication||PX090301030000||Reason for Contraindication||4||N/A|
|PX090301_Pre_Bronchodilator_FEV1||PX090301040000||Pre-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 1||4||N/A|
|PX090301_Pre_Bronchodilator_FEV2||PX090301050000||Pre-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 2||4||N/A|
|PX090301_Pre_Bronchodilator_FEV3||PX090301060000||Pre-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 3||4||N/A|
|PX090301_Pre_Bronchodilator_FVC1||PX090301070000||Pre-Bronchodilator Forced Vital Capacity (FVC) 1||4||N/A|
|PX090301_Pre_Bronchodilator_FVC2||PX090301080000||Pre-Bronchodilator Forced Vital Capacity (FVC) 2||4||N/A|
|PX090301_Pre_Bronchodilator_FVC3||PX090301090000||Pre-Bronchodilator Forced Vital Capacity (FVC) 3||4||N/A|
|PX090301_Post_Bronchodilator_FEV1||PX090301100000||Post-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 1||4||N/A|
|PX090301_Post_Bronchodilator_FEV2||PX090301110000||Post-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 2||4||N/A|
|PX090301_Post_Bronchodilator_FEV3||PX090301120000||Post-Bronchodilator Forced Expiratory Volume (FEV1) in 1 second 3||4||N/A|
|PX090301_Post_Bronchodilator_FVC1||PX090301130000||Post-Bronchodilator Forced Vital Capacity (FVC) 1||4||N/A|
|PX090301_Post_Bronchodilator_FVC2||PX090301140000||Post-Bronchodilator Forced Vital Capacity (FVC) 2||4||N/A|
|PX090301_Post_Bronchodilator_FVC3||PX090301150000||Post-Bronchodilator Forced Vital Capacity (FVC) 3||4||N/A|
|PX090301_Percent_Baseline_FEV||PX090301160000||Percent of Baseline Forced Expiratory Volume in 1 second||4||N/A|
|PX090301_Pre_Bronchodilator_FEV||PX090301160100||Pre-Bronchodilator Forced Expiratory Volume (FEV1)||4||N/A|
|PX090301_Percent_Predicted_FEV||PX090301170000||Percent of Predicted Forced Expiratory Volume in 1 second||4||Variable Mapping|
|PX090301_Pre_Bronchodilator_FVC||PX090301170100||Pre-Bronchodilator Forced Vital Capacity (FVC)||4||N/A|
|PX090301_Post_Bronchodilator_FEV||PX090301180100||Post-Bronchodilator Forced Expiratory Volume (FEV1)||4||N/A|
|PX090301_Post_Bronchodilator_FVC||PX090301190000||Post-Bronchodilator Forced Vital Capacity (FVC)||4||N/A|