Study of the impact of indacaterol on the individual lives and health status of patients with chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN67880705 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67880705 |
| Secondary identifying numbers | CQAB149BGB01 |
- Submission date
- 11/04/2012
- Registration date
- 10/05/2012
- Last edited
- 07/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Novartis Pharmaceuticals UK Ltd
200 Frimley Business park
Frimley
GU16 7SR
United Kingdom
Study information
| 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 |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | INdacaterol effect on Health status in COPD: A real Life patient Experience prospective observational study (INHALE) |
| Study acronym | INHALE |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 atients 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 study start date | 01/05/2012 |
| Completion date | 01/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2012 |
| Date of final enrolment | 01/10/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GU16 7SR
United Kingdom
Sponsor information
Industry
200 Frimley Business Park
Frimley
GU16 7SR
United Kingdom
"ROR" |
https://ror.org/039s6n838 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/06/2017: No publications found in PubMed, verifying study status with principal investigator.
