Common Protocol Template Asthma Library v2.0
Common Protocol Template Asthma Library v2.0
Section in Common Protocol Template (CPT)
Library Content
1. Protocol Synopsis Objectives and Endpoints
Protocol Synopsis Objectives and Endpoints
4. Objectives and Endpoints
Objectives and Endpoints
5. Study Design
Instructional text including Definitions of
Common Assessments
10.3 Statistical Analyses
Instructional text
11. References
References applicable to the Asthma library
Pulmonary Function Test Manual (not included
with this template)
Instructional text on suggested content for
the Pulmonary Function Test Manual (not
included with this template)
1.
Synopsis Objectives and Endpoints
and
4.
Objectives and Endpoints (main body)
Objectives
Endpoints
Primary

To evaluate the efficacy of [x mg of
Study Treatment] administered
[frequency] to subjects with [severity
of asthma] asthma
Spirometry FEV1

The absolute change in the percentage of
predicted FEV1 from baseline to [Week X]
OR

To evaluate the efficacy of [x mg of
Study Treatment]administered
[frequency] compared with
[comparator] in participants with
[severity of asthma] asthma
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OR

The increase [magnitude of change] in
FEV1 from baseline to [Week X]
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Common Protocol Template Asthma Library v2.0
Objectives
Endpoints
Secondary


To evaluate the efficacy of [x mg of
Study Treatment] administered
[frequency] to subjects with [severity
of asthma] asthma
To evaluate the efficacy of [x mg of
Study Treatment]administered
[frequency] compared with
[comparator] in participants with
[severity of asthma] asthma


Forced Vital Capacity(FVC)
The absolute change in the percentage of
predicted FVC from baseline to [Week X]
FEV1/FVC Ratio or %
The change from baseline in FEV1/FVC (or
change in the percentage from baseline) to
[Week X]
Asthma Symptoms
Clinical Asthma Exacerbations (CAEs)
 The incidence of severe CAEs
compared to control at [Week X]
 The incidence of moderate CAEs
compared to control at [Week X]
Examples of CAEs include the following:
 Hospitalization, emergency room (ER),
or Urgent Care (UC) treatment with
systemic steroids
 Initiation or increased dose (from a
stable maintenance dose) of systemic
corticosteroids (tablets, suspension, or
injection) for at least 3 days to prevent
a serious outcome
 Asthma-specific ICU
admissions/intubations
 Asthma-related deaths

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Rescue Medication
The reduction in number of rescue
occasions compared to control at [Week X]
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Common Protocol Template Asthma Library v2.0
Objectives
Endpoints
Exploratory

To evaluate the allergic response to [x
mg of Study Treatment to the skin
prick test]
Allergen Skin Test
The response to the standard skin prick test at
[Week X]
5.Study Design
Definitions of Common Assessments


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
Forced Expiratory Volume in 1 second (FEV1) is the volume (L or mL) of air that is
exhaled in the first second of a forced spirometry test.
Percent Predicted FEV1 is the participant’s best FEV1 for the assessment divided by the
participant’s predicted normal value multiplied by 100.
Forced Vital Capacity (FVC) is the volume of air expired over the course of a forced,
maximal exhalation after a full inhalation. It is equal to the sum of inspiratory reserve
volume, tidal volume, and expiratory reserve volume.
Percent Predicted FVC is the FVC value divided by the participant’s predicted normal
value, multiplied by 100.
Peak Expiratory Flow (PEF) is the maximal flow rate (L/sec or L/min) achieved during a
maximally forced exhalation. The PEF is quite variable and not recommended as a primary
endpoint.
Percent Predicted PEF is the maximal flow rate achieved during a maximally forced
exhalation divided by the participant’s predicted normal value.
FEV1/FVC Ratio (or percentage) provides a measure of the proportion of total FVC that is
expelled during the first second of a forced exhalation. This measure is a good index of
airflow obstruction.
FEF25-75 is forced expiratory flow at 25% to 75% of vital capacity, also called maximal
mid-expiratory flow (L/sec).
Percent predicted FEF25-75 is the FEF25-75 value divided by the participant’s predicted
normal value, multiplied by 100.
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Common Protocol Template Asthma Library v2.0
10.3 Statistical Analyses
11.0 References
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Reddel HK, Taylor DR, Bateman ED, et al. An official American Thoracic Society /
European Respiratory Society statement: asthma control and exacerbations: standardizing
endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;
180(1);59-99.
Chung KF et al. ERS/ETS Guidelines on severe asthma Eur Respir J 2014; 43:343-373.
Quanjer PH, Tammeling GJ, Cotes JE et al. Lung volumes and forced ventilator flows.
Report Working Party Standardization of Lung Function Tests, European Community for
Coal and Steel. Official Statement of the European Respiratory Society. Eur Respir J 1993;
6:Suppl. 16:5-40.
Tojo N, Suga H, Kambe M. Lung Function Testing – The Official Guideline of the Japanese
Respiratory Society. Rinsho Byori 2005 53(1):77-81.
Clinical Data Interchange Standards Consortium (CDISC), Version 1 of Therapeutic Area
Data Standards User Guide for Asthma, November 26, 2013.
© 2015 TransCelerate BioPharma
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