View Study

Status: Planned First registered on: 24/03/2023

Last updated on: 24/03/2023

1. Study identification

EU PAS Register NumberEUPAS104132

Official titleExploring different composite definitions of responders and non-responders to biologic treatment for severe asthma

Study title acronymFULL BEAM

Study typeObservational study

Brief description of the study

Was this study requested by a regulator?No

Is the study required by a Risk Management Plan (RMP)? Not applicable

Regulatory procedure number (RMP Category 1 and 2 studies only)

Other study registration identification numbers and URLs as applicable

2. Research centres and Investigator details

Coordinating study entity

Centre to which the investigator belongsOPRI Pte Ltd

Department/Research groupObservational and Pragmatic Research Institute Pte Ltd

Organisation/affiliationOPRI Pte Ltd

Website/Homepagewww.opri.sg

Details of (Primary) lead investigator

Title Professor

Last name Price

First name David

Is this study being carried out with the collaboration of a research network?

Yes

Optimum Patient Care (OPC)

Respiratory Effectiveness Group (REG)

Other centres where this study is being conducted

Not applicable (single centre)

Countries in which this study is being conducted

International study

Argentina

Australia

Bulgaria

Canada

Colombia

Denmark

Greece

India

Ireland

Italy

Japan

Korea, Republic of

Kuwait

Mexico

Poland

Portugal

Saudi Arabia

Taiwan

United Arab Emirates

United Kingdom

United States

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed01/03/2022

Start date of data collection02/05/2022

Start date of data analysis

Date of interim report, if expected30/12/2022

Date of final study report30/04/2023

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

Names(s)Approximate % funding

Pharmaceutical companiesAstraZeneca60

Charities

Government body

Research councils

EU funding scheme

OtherOPRI Pte Ltd40

5. Contact details for enquiries

Scientific Enquiries

Title Professor

Last name Price

First name David

Address line 15a Coles Lane

Address line 2Oakington

Address line 3

CityCambridge

PostcodeCB24 3BA

CountryUnited Kingdom

Phone number (incl. country code)44-7787-905057

Alternative phone number

Fax number (incl. country code)

Email address dprice@opri.sg

Public Enquiries

Title Professor

Last name Price

First name David

Address line 15a Coles Lane

Address line 2Oakington

Address line 3

CityCambridge

PostcodeCB24 3BA

CountryUnited Kingdom

Phone number (incl. country code)44-7787-905057

Alternative phone number

Fax number (incl. country code)

Email address dprice@opri.sg

11. Scope of the study

What is the scope of the study?

Disease epidemiology

Primary scope : Disease epidemiology

12. Main objective(s)

What is the main objective of the study?

1)Define the study population To describe pre-biologic demographic, clinical and functional characteristics of patients initiating biologics, overall and by biologic class 2) Quantify levels of response and characterize patients by levels of response To operationally assess levels of response to biologics (from non-response to highest level of response) in individual domains

Are there primary outcomes?Yes

Clinical remission and response to treatment. While clinical remission will be assessed in all patients irrespective of their status pre-biologic initiation, response can only be assessed in patients impaired when initiating the treatment. Impairment will be defined for each domain independently as: 1) exacerbations: ≥2 exacerbations in the year preceding biologic initiation; 2) long-term OCS use

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Registry-based cohort study

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

Objective 1 aims at describing the study population used in objectives 2 and 3. To this end, the pre-biologic asthma-related outcomes will first be described individually and in composite variables. For individual asthma-related outcomes, both continuous and categorical variables will be used. The distributions will be compared between initiated biologic class using t-tests, Kruskall Wallis tests, or Person’s Chi-squared tests as appropriate. The proportion of patients responding to biologics as defined in section 5 will be computed overall and by biologic classes, for each individual domain and composite definition of response. Patient characteristics will be described by levels of response using means, standard deviations, medians and interquartile ranges for continuous variables and numbers and percentages for categorical variables.