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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 study consists of two phases:
The maximum time from screening to end of study visit is12 weeks, with a follow up taking place 30 days after the final visit .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiromax Inhaler | Active Comparator | Evaluation of correct use of Spiromax inhaler - 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 inhaler | Active Comparator | Turbohaler® - Symbicort® 160/4.5 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate). 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 |
|
| Diskus Inhaler | Active Comparator | Diskus® inhaler - Seretide Diskus 50/250 mcg ® or 50/500 mcg (50 mcg salmeterol & 250/500 mcg fluticasone propionate). Dose of one inhalation twice a day for 1 week. Additional 8 weeks in one subgroup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiromax (budesonide/formoterol) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of Spiromax , Turbuhaler and Diskus devices | number of attemps required to acheive optimal use | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Short term maintenance of correct use | Ease of use: Number of errors after 1 week use | 1 weeks of treatment (cross sectional phase) |
| Long term maintenance of correct use | number of errors after 8 additional weeks of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Papi, MD | Università degli Studi di Ferrara | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3) Fondazione S. Maugeri - IRCCS - Dipartimento di Pneumologia Riabilitativa | Cassano delle Murge | Bari | 70020 | Italy | ||
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Turbohaler (budesonide/formoterol) | Device | 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 |
|
| Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) | Device | 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 |
|
| 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 | 8 weeks of treatment at the end of the longitudinal phase |
| University Hospital S Anna |
| Ferrara |
| Fe |
| 44124 |
| Italy |
| 4) Clinica di Malattie dall'Apparato Respiratorio Fondazione Salvatore Maugeri | Tradate | Varese | 21049 | Italy |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |