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

NCT02757209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-01-29

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Consorzio Futuro in Ricerca

    lead OTHER

Principal Investigators

  • Alberto Papi, MD · Università degli Studi di Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757209 on ClinicalTrials.gov