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Status: Finalised First registered on: 04/10/2013

Last updated on: 25/03/2015

1. Study identification

EU PAS Register NumberEUPAS4902

Official titleEvaluation of patients with chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) who would benefit from aclidinium bromide treatment.

Study title acronym

Study typeObservational study

Brief description of the studyA retrospective, observational study characterising patient groups already within the OPCRD with chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) who may benefit from initiation of long acting muscarinic antagonist (LAMA) therapy or a switch from tiotropium for safety reasons

Was this study requested by a regulator?No

Is the study required by a Risk Management Plan (RMP)?

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 belongsRIRL

Department/Research group

Organisation/affiliationResearch in Real Life Ltd.

Website/Homepagewww.rirl.org

Details of (Primary) lead investigator

Title Dr

Last name Davis

First name Emily

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

Other centres where this study is being conducted

Not applicable (single centre)

Countries in which this study is being conducted

National study

United Kingdom

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

PlannedActual

Date when funding contract was signed17/09/201317/09/2013

Start date of data collection01/10/201301/10/2013

Start date of data analysis30/10/201328/10/2013

Date of interim report, if expected

Date of final study report31/12/201330/12/2013

4. Sources of funding

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

Names(s)Approximate % funding

Pharmaceutical companiesAlmirall100

Charities

Government body

Research councils

EU funding scheme

5. Contact details for enquiries

Scientific Enquiries

Title Professor

Last name Price

First name David

Address line 1University of Aberdeen

Address line 2

Address line 3

CityAberdeen

PostcodeAB24 3FX

CountryUnited Kingdom

Phone number (incl. country code)441223967855

Alternative phone number

Fax number (incl. country code)

Email address david@rirl.org

Public Enquiries

Title Professor

Last name Price

First name David

Address line 1University of Aberdeen

Address line 2

Address line 3

CityAberdeen

PostcodeAB24 3FX

CountryUnited Kingdom

Phone number (incl. country code)441223967855

Alternative phone number

Fax number (incl. country code)

Email address david@rirl.org

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?

To characterise populations of patients with chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) who could benefit from treatment with aclidinium bromide as an alternative to Tiotropium

Are there primary outcomes?Yes

To characterise the aclidinium bromide eligible population. The proportion of patients who are being incorrectly treated with tiotropium and the proportion of patients not receiving any LAMA therapy but that would be justified in having treatment; and could therefore be started on aclidinium bromide, will be evaluated.

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Retrospective observational database 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

Summary statistics will be calculated for the following variables by LAMA therapy and compared: • Demographics (including age, sex, BMI, smoking status) • Co-morbidities • Number of exacerbations in the year before the index date (ATS and clinical definition) • GOLD group status • CKD diagnostic code For variables measured on the interval or ratio scale, summary statistics produced will be: • Sample size (n) • Percentage non missing • Mean • Variance/standard deviation • Range (minimum- maximum) • Median • Inter-quantile range (25th and 75th percentile) For categorical variable the summary statistics will include: • Sample size (n) • Range (if applicable) • Count and percentage by category (distribution) Outcomes will be compared using a Mann Whitney U test/Chi squared Test (for variables measured on the interval or ratio scale/ categorical variables respectively.)