Please select the eligibility criteria that correspond to the clinical trial below.
Title: Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial
Brief Summary: Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.

Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.

Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control.

Ethics and dissemination:

Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.


Options:
A: Inclusion Criteria:

* Confirmed Gold III/IV COPD
* Current or ex-smoker with a smoking history ≥ 10 pack-years
* At least one COPD exacerbation leading to hospitalization in the year before selection.

Exclusion Criteria:

* LTOT for another reason than COPD
* Severe concomitant disorder associated with a limited probability of survival (\< 6 months)
* Tracheostomy
* Long term oral corticosteroids therapy
B: Inclusion Criteria:

* COPD new GOLD classification (B, C and D class) and a spirometry in the previous year and
* Systolic and/or diastolic CHF defined at least by an echocardiogram performed in clinical stability; II, III and IV New York Heart Association class and optimized drug therapy.
* Informed consent signed

Exclusion Criteria:

* Physical activity limitations caused by non-cardiac and/or pulmonary problems
* Obstructive Cardiomyopathies and/or myocarditis
* Non cardiac and/or pulmonary pathologies that would cause the death of the patient during the study
* Poor adherence and compliance of the patient
C: Inclusion Criteria:

* Patients with a diagnosis of COPD or Asthma, medicated with any kind of inhaler device (pressurized Metered Dose Inhaler (pMDI) with or without Spacer, Dry Powder Inhaler (DPI) or Soft Mist), aged ≥65 years and being a regular user of primary health care services (defined as having at least one consultation performed in the last two years with his/her own Family Doctor). In order to minimize diagnostic inaccuracy, Asthma and COPD diagnosis will be reviewed in every participant at baseline prior to enrolment and according to GINA and GOLD strategies.

Exclusion Criteria:

* Severe or acute illness (such as unstable cardiovascular status, unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax (within one month), recent thoracic, abdominal or eye surgery (within one month), acute nausea or vomiting, severe respiratory distress, dementia). Patients with intermittent asthma, as well as COPD patients with mild obstruction (GOLD class I) will be excluded, since these patients do not need to take inhaler medication on a daily basis, and tend to have a low frequency of disease exacerbations.
D: Inclusion Criteria:

* Must be 18 years old or above
* Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
* Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
* Able and willing to take inhaled medication.
* Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
* Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.

Exclusion Criteria:

* Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months

Answer: C