This is a randomized, multi-center, active-controlled, repeated measures design study in male and female patients 60 years of age and older with persistent asthma or COPD. Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano delle Murge (Ba), Tradate. The primary efficacy parameter of the study is inhaler device usability (expressed as total number of repeated attempts required to achieve optimal use).
Asthma and Chronic Obstructive Pulmonary Disease (COPD) are common conditions with an increasing prevalence worldwide. Inhaled therapy for these conditions has a number of advantages over systemic therapy, including reduced side effects and quicker onset of action. However, poor asthma control is common, despite available effective treatment .This is partially related to low adherence and to difficulties in using inhaler devices. Among patients with chronic respiratory disorders, 18% discontinued the prescribed inhaler treatment because of troubles with the device (Santus 2012). Some devices are not easy to handle, or require breathing abilities, which reduce the effectiveness in real life, especially in elderly.Since mistakes in inhaler technique are very common affecting drug delivery and efficacy, a correct inhaler technique training is fundamental. A single site study in 2012 (Press 2012) found that patients given verbal and written instructions followed by demonstrations of inhaler use had better inhaler technique than patients given verbal and written instructions only. The authors concluded that larger multi-centred studies were needed to evaluate hospital-based-education. Proposals to improve inhalers use are based on three key points: * the choice of the best device paying attention to patient needs and abilities (personalized therapy) * a complete explanation of the correct use (patient training) * a regular re-check to evaluate the maintenance of a correct technique (monitoring) The study consists of two phases: * A cross over phase: 3 periods of 1 week each. During the training visit at the beginning of each week period, patients will be instructed on the correct use of one of the 3 devices. Correct use and maintenance of correct use after 1 week will be assessed. * A longitudinal phase: patient will be treated with the last inhaler device used during the cross over phase for 8 additional weeks. The maximum time from screening to end of study visit is12 weeks, with a follow up taking place 30 days after the final visit .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
84
DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup
Turbohaler® (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate)- Symbicort® 160/4.5. Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup
3) Fondazione S. Maugeri - IRCCS - Dipartimento di Pneumologia Riabilitativa
Cassano delle Murge, Bari, Italy
University Hospital S Anna
Ferrara, Fe, Italy
4) Clinica di Malattie dall'Apparato Respiratorio Fondazione Salvatore Maugeri
Tradate, Varese, Italy
Usability of Spiromax , Turbuhaler and Diskus devices
number of attemps required to acheive optimal use
Time frame: day 1
Short term maintenance of correct use
Ease of use: Number of errors after 1 week use
Time frame: 1 weeks of treatment (cross sectional phase)
Long term maintenance of correct use
number of errors after 8 additional weeks of use
Time frame: 8 weeks of treatment at the end of the longitudinal phase
Patient's preference for different devices
Patient's preference for different devices b using PAPSQ questionnaire and VAS scales
Time frame: 8 weeks of treatment at the end of the longitudinal phase
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Diskus® inhaler(50mcg salmeterol\&250/500mcg fluticasone propionate)-Seretide Diskus 50/250mcg® or 50/500mcg.Dose of 1inhalation twice a day for1 week.Additional 8 weeks in1subgroup