Condition category
Respiratory
Date applied
11/04/2012
Date assigned
10/05/2012
Last edited
17/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Clinical studies provide useful information regarding both the safety and effectiveness of medicines, but clinical trial settings are not always as close to a real-world setting as they could be, often due to the excluding of patients taking specific medications or with other specific conditions, and the patients are also often intensively monitored throughout the study. Indacaterol is a drug used for the treatment of chronic obstructive pulmonary disease (COPD). It is taken once a day to open up the airways that will have become narrowed as part of the disease process of COPD. The aim of this study is to measure the impact of indacaterol on individual patients in a real-world setting, where the patients have been prescribed indacaterol as their standard therapy following a clinical assessment for their COPD.

Who can participate?
The study is open to patients in selected GP practices in the UK that have chosen to participate. Patients must be aged over 18 and have been prescribed indacaterol for COPD.

What does the study involve?
This study uses data from routine clinical examinations. In addition to standard measurements, patients will also be requested to complete two straightforward questionnaires at specified timepoints during the study andwill also be requested to rate their overall opinion of the effectiveness of indacaterol at the end of the study. Patients in the study will be monitored for a total of 6 months, with a visit between 6 and 8 weeks after the start of the study.

What are the possible benefits and risks of participating?
There may be a potential benefit for participating patients in terms of improved monitoring of their COPD, though this study has been designed to be close to the standard monitoring of COPD patients starting a new medication. The only potential impact for patients is the short amount of time required to complete the two short questionnaires.

Where is the study run from?
Novartis Pharmaceuticals UK Ltd.

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

Who is funding the study?
Novartis Pharmaceuticals UK Ltd.

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
GU16 7SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CQAB149BGB01

Study information

Scientific title

INdacaterol effect on Health status in COPD: A real Life patient Experience prospective observational study (INHALE)

Acronym

INHALE

Study hypothesis

Whilst there have been clinical trials of indacaterol showing the improvement of objective measures of COPD such as Forced expiratory volume in one second (FEV1) and dyspnoea score, there is to date no information on its impact on individual patient lives in the real world. Novartis are keen to undertake a prospective observational study of the impact of indacaterol on individual patient lives in the real world by looking at patient experience in the non‐RCT population.

Ethics approval

This observational study will be submitted for ethical review via the National Research Ethics Service (NRES) and appropriate PCT (or equivalent) and practice research governance approval will be btained before the study commences in each location. Patient consent will be sought for participation in the study.

Study design

Prospective observational multi‐centre research study in GP practices clustered within up to 10 UK primary care trusts (PCTs)

Primary study design

Observational

Secondary study design

Other

Trial setting

GP practices

Trial type

Other

Patient information sheet

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

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Patients in the study will have been prescribed indacaterol as part of routine clinical practice. Patients will be asked to complete the COPD Assessment Test (CAT) at baseline, 6-8 weeks and 6 months after initiation, a life impact questionnaire at 6-8 weeks after initiation and a Global Evaluation of Treatment Effectiveness (GETE) questionnaire at 6 months after initiation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Absolute CAT scores and mean standard deviation (SD) change from baseline in CAT score at 6‐8 weeks after initiation of indacaterol

Secondary outcome measures

1. Mean (SD) change from baseline in CAT score at 6 months fter initiation of indacaterol
2. Qualitative description of the impact of indacaterol on the atient’s life at 6‐8 weeks after initiation of indacaterol
3. Distribution and summary statistics of physician GETE at 6‐8 eeks and 6 months after initiation of indacaterol
4. Distribution and summary statistics of patient GETE at 6 onths after initiation of indacaterol
5. Distribution and summary statistics of FEV1 throughout the bservation period
6. Distribution and summary statistics of MRC dyspnoea cores throughout the observation period
7. Description of study sample at baseline

Overall trial start date

01/05/2012

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with active diagnosis of COPD, confirmed by spirometry, documented in medical notes
2. Patients who are newly‐prescribed indacaterol as part of routine clinical practice

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 patients

Participant exclusion criteria

1. Patients who have previously received maintenance therapy for COPD symptoms e.g. Long acting beta agonists (LABAs), long acting antimuscarinics (LAMAs), LABA + inhaled corticosteroid (ICS)
2. Patients unable or unwilling to consent to participation in the study
3. Patients unable or unwilling to complete the study questionnaires
4. Patients who have participated in any interventional clinical trial for indacaterol
5. Patients who have previously been prescribed indacaterol

Recruitment start date

01/05/2012

Recruitment end date

01/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Novartis Pharmaceuticals UK Ltd
Frimley
GU16 7SR
United Kingdom

Sponsor information

Organisation

Novartis Pharmaceuticals UK Ltd (UK)

Sponsor details

200 Frimley Business Park
Frimley
GU16 7SR
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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