NCT02757209

Comparative Study on Usability of Inhaler Devices in Adults With Asthma or COPD

STUDY NUMBER: PMC-101-APT Usability and Adherence of Spiromax® Inhaler Device, Turbohaler® and Diskus® Inhaler Devices for Fixed Combination of Corticosteroid/Long-acting beta2- Agonist, in Adults With Asthma or COPD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Consorzio Futuro in Ricerca · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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 .

Conditions

• Asthma
• COPD

Interventions

Type	Name	Description
DEVICE	Spiromax (budesonide/formoterol)	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
DEVICE	Turbohaler (budesonide/formoterol)	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
DEVICE	Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)	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

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-05-02
• Last updated: 2018-01-29

Locations

3 sites across 1 country: Italy