Condition category
Respiratory
Date applied
11/04/2012
Date assigned
10/05/2012
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Allergic asthma is the most common type of asthma, where symptoms such as coughing, wheezing, chest tightness and breathlessness begin when the body reacts to something it is allergic to. Omalizumab is a drug licensed for the treatment of severe allergic asthma. A study has demonstrated that use of omalizumab reduces oral corticosteroid use, hospitalisations and A&E visits, and increases patients’ quality of life. In order to follow on from and reinforce the findings from this study, we are now undertaking a further study to collect data from the point of decision to prescribe omalizumab.

Who can participate?
Patients aged 16 and over who are going to receive at least one dose of omalizumab for the treatment of severe persistent allergic asthma as part of normal clinical care.

What does the study involve?
Patients are treated as per standard clinical practice with omalizumab, but are also requested to complete a breathing test and questionnaires about asthma and their quality of life after 16 weeks, 8 months and 12 months. There is therefore little deviation from standard omalizumab care from the patients’ perspective.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Novartis Pharmaceuticals (UK)

When is the study starting and how long is it expected to run for?
March 2012 to August 2013

Who is funding the study?
Novartis Pharmaceuticals (UK)

Who is the main contact?
Dr Amr Radwan

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amr Radwan

ORCID ID

Contact details

Novartis Pharmaceuticals UK Ltd
200 Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CIGE025AGB04

Study information

Scientific title

The impact of omalizumab treatment in UK clinical practice Asthma Patient Experience on Xolair® (Omalizumab) (the APEX II study)

Acronym

APEX-II

Study hypothesis

Null Hypothesis: The initiation of omalizumab in the treatment of severe persistent allergic asthma in normal clinical practice is associated with a difference of less than 25% in the mean daily dose of oral corticosteroids (OCS) per patient in the 12 months post‐ vs the 12 months pre-initiation.

Ethics approval

This observational study will be submitted for NHS REC review. MHRA requirements for spontaneous reporting of adverse events will be met. Patient consent will be sought for research use of medical records. Local management (R&D) approval will be sought to conduct the study at each site.

Study design

Multi‐centre observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe allergic asthma (consistent with the licence for omalizumab).

Intervention

This study will investigate patients who are prescribed omalizumab treatment as part of routine clinical practice. Retrospective and prospective clinical assessments will be undertaken by a member of the clinical team in routine clinic. Patients will also be asked to complete the Asthma Control Test questionnaire (ACT) and Asthma Quality of Life Questionnaire (AQLQ) at baseline, 16 weeks, 8 months and 12 months post-initiation of omalizumab.

Intervention type

Drug

Phase

Not Applicable

Drug names

Omalizumab

Primary outcome measures

The difference in the mean (SD) daily dose of OCS per patient in the 12 months pre- versus post-initiation of omalizumab and its 95% confidence interval (CI)

Secondary outcome measures

1. The difference in lung function (FEV1 % predicted) at baseline versus 16 weeks, 8 months and 12 months post-initiation of omalizumab
2. The difference in patient reported outcomes (scales ACT & AQLQ) at baseline versus 16 weeks, 8 months and 12 months post-initiation of omalizumab
3. The difference in mean (SD) NHS secondary care resource utilisation in the 12 months pre- versus the 12 months post-initiation of omalizumab
4. The proportion of patients stopping, the proportion reducing and the proportion stopping OR reducing OCS within 12 months following initiation of omalizumab
5. The correlation coefficient between stopping OCS ang change in AQLQ from baseline to 16 weeks, 8 months and 12 months post-initiation of omalizumab
6. The difference in the number of documented asthma exacerbations in the 12 months pre- versus the 12 months post-initiation of omalizumab
7. The correlation coefficient betweeen change in number of exacerbations and change in lung function from basline to 16 weeks, 8 months and 12 months post-initiation of omalizumab
8. The difference in the number of working/education days lost in the 12 months pre versus the 12 months post-initiation of omalizumab
9. Distribution of concomitant steroid-sparing asthma medications in the 12 months pre versus the 12 months post-initiation of omalizumab treatment
10. The proportion of patients in whom initiation of omalizumab was compliant with NICE (English and Welsh centres) and SMC (Scottish centres) criteria for omalizumab use
11. The proportion of patients classed by the clinician as 'responders' to omalizumab treatment at 16 weeks
12. Distribution of characteristics of patients who have been prescribed omalizumab in normal clinical priactice (age, sex, race, smoking status, height, weight, allergies and co morbidities at baseline)
13. The difference in patient weight at baseline and12 months post-omalizumab initiation

Overall trial start date

01/03/2012

Overall trial end date

01/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient to receive at least one dose of omalizumab for the treatment of severe persistent allergic asthma as part of normal clinical care
2. Patient aged 16 or over at initiation of omalizumab

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 adults

Participant exclusion criteria

1. Complete patient medical record for the 12 months pre-initiation of omalizumab is not available for review
2. Medical record contains insufficient data to complete the baseline study dataset (for patients recruited to the study after omalizumab initiation)
3. Patient declines to consent to research access to the medical record and/or researcher contact with the GP to obtain a complete study dataset
4. Previous bronchial thermoplasty
5. Previous omalizumab use
6. Current participation in any interventional trial of asthma treatment

Recruitment start date

01/03/2012

Recruitment end date

01/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Novartis Pharmaceuticals UK Ltd
Surrey
GU16 7SR
United Kingdom

Sponsor information

Organisation

Novartis Pharmaceuticals (UK)

Sponsor details

200 Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
United Kingdom

Sponsor type

Industry

Website

http://www.novartis.co.uk/

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals UK Limited

Alternative name(s)

Novartis UK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes