Comparative Study on Usability of Inhaler Devices in Adults With Asthma or COPD (PMC-101-APT)

This is an interventional supportive care trial for Asthma focused on measuring ASTHMA, COPD, budesonide, formoterol, Salmeterol, Fluticasone, Spiromax, DPI, Diskus Read More

Inclusion Criteria:

• Informed consent. Written informed consent/assent signed and dated by the patient before conducting any study related procedure.
• Age. Male or female patients 60 years and older as of the Screening Visit (SV)
• Asthma or COPD diagnosis. Previous or new Asthma/COPD diagnosis in accordance with the Global Initiative for Asthma (GINA) or Global initiative for chronic Obstructive Lung Disease (GOLD).
• Severity of respiratory disease: Persistent asthma, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months duration. COPD, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months.
• Stable state. Patients without exacerbations and without change in the previous treatment for at least 4 weeks prior to the visit 1 as defined by clinical history.
• Comorbidities. No concomitant severe comorbidities which could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study observations/results, or put the patient at increased risk during the study.
• Current Therapy: Patients needing combination ICS/LABA already in treatment with PDI (Turbohaler) or Diskus.
• Short-Acting beta2-Agonists: All patients must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at the visit 1 for use as needed for the duration of the study.
• Patients must be able to withhold all inhaled short-acting betapathomimetic bronchodilators for at least 6 hours prior to all study visits.
• Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc.).

Exclusion Criteria:

• Asthma severity. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
• COPD severity. COPD with a pre-bronchodilator FEV1 < 30% and/or FEV1 30-50% but requiring long term oxygen therapy.
• Exacerbations. Any asthma/COPD exacerbation within one month of the visit 1. A patient must not have had any hospitalisation for asthma/COPD within 6 months prior to the visit 1.
• Respiratory infections. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the visit 1.
• Comorbidities. Historical or current evidence of a clinically significant comorbidity including, but not limited to: cardiovascular (e.g. congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological (e.g. immunologic compromise), neuropsychological, endocrine (e.g. uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g. poorly-controlled peptic ulcer, gastroesophageal reflux disease), pulmonary (e.g. bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, lung cancer) or history of a positive test for HIV, hepatitis B or hepatitis C infection. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
• History of any adverse reaction. History of any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the inhalers used in the study (e.g. lactose in the dry powder inhalers).
• Use of immunosuppressive medications. Use of immunosuppressive medications within 12 weeks prior visit 1 and during the study, including use of systemic corticosteroids. Immunotherapy at a stable dose for at least 90 days prior to the visit 1 and throughout the study for the treatment of allergies is permitted.
• Smoking. Current smokers are excluded. A patient may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
• Concomitant participation to other research study. Participation to another research study investigational drug study within the 30 days (starting at the final follow-up visit) preceding the visit 1 or planned participation in another investigational drug study at any time during this study.