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:

* 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.
B: Inclusion Criteria:

1. Be 18 years or older
2. Be able to provide informed consent
3. Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center
4. Have a smartphone or tablet compatible with activity tracking devices
5. Plan to be discharged to home

Exclusion Criteria:

Have no medical condition which prohibits them from ambulating or plan for any medical procedure over the next 6 months that would prohibit them from ambulating.
C: Inclusion Criteria:

1. Male or female older than 40 years
2. Clinical diagnosis of COPD (confirmed with a post-bronchodilator forced expiratory volume in 1 s \[FEV1\]/forced vital capacity \[FVC\] ratio ≤70%) at least 4 weeks prior to the study and post-bronchodilator FEV1 is 50% or less than the predicted value
3. Former smokers or current smokers with at least a 10 pack-year history
4. A history of exacerbation (scheduled/unscheduled visits to primary care physicians, specialists or allied healthcare professionals, or emergency room, or hospitalization due to purulent sputum or increased sputum, or increased dyspnea) in the previous year (at least one)
5. Chronic bronchitis (cough and sputum production for at least three months within two years)
6. Able to have the signed written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit
2. Known a1-antitrypsin deficiency
3. Need for long-term oxygen therapy
4. Moderate to severe liver impairment (Child-Pugh B or C)
5. Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc)
6. Severe acute infectious diseases
7. Cancers
8. Subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term) except short-term systemic corticosteroids)
9. Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster
10. Subjects with congestive heart failure (NYHA grades 3 and 4)
11. Subjects with a history of depression associated with suicidal ideation or behavior
12. Clinically meaningful bronchiectasis
13. Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception
14. Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients
15. Patients with previous Roflumilast therapy within past 3 months
D: Inclusion Criteria:

* Patient at one of the participating primary care clinics (at least 1 visit in past 12 months)
* Age 40 and older
* Speaking English or Spanish
* Plan to continue to be seen at current clinic and to not leave the area for \>2 months anytime in the next 9 months or to be absent at 9 or 15 months
* COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) \<.70 of FEV1/FVC of .70 to .74 and diagnosis of COPD by the study pulmonologist
* Willingness to attempt spirometry
* At least moderate COPD, defined as at least one of the following:

  * Ever Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted
  * 1 or more emergency department (ED) visit for COPD exacerbation in past 12 months
  * 1 or more hospital stays for COPD exacerbation in past 12 months
  * 1 or more prescriptions for oral prednisone for a COPD exacerbation in past 12 months
  * Ever on home oxygen therapy
  * Ever outpatient percutaneous oxygen saturation of \</=88%
  * Ever outpatient partial pressure of oxygen (ppO2) by arterial blood gas (ABG) of \</=55mm Hg
  * At least 3 outpatient visits for COPD in past 12 months AND (a current COPD Assessment Test (CAT) score of \>/=10 OR an modified Medical Research Council (mMRC) score of \>/=2).
  * Currently using tiotropium inhaler or combination inhaled corticosteroid and long-acting beta agonist

Exclusion Criteria:

* Unable to participate in the study due to mental or physical impairment
* Severe or terminal illness that precludes focus on COPD
* No phone

Answer: A