Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment (NCT02384577)

Study summary

The main aim of the study is to investigate patient satisfaction in the treatment of asthma and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.

Read the detailed description

The study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or COPD.

Conditions studied

Patient Satisfaction

In context

Lead sponsor

Teva Pharma GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Adult asthma or COPD-patients

Inclusion criteria

male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
patients who recently changed medication to DuoResp® Spiromax or are about to do so
capacitated person with present declaration of consent

Exclusion criteria

Exclusion Criteria:

diseases contraindicated in accordance with the summary of product characteristic
patients who take part in interventional clinical trials parallel or during the last 4 weeks
patient shows conditions or diseases that might disturb the monitoring according to the physician
patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
patients involved in the planning and construction of the study (Teva staff and employees of the centres)
patient is incapable of giving consent

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 4,034 participants (actual)
Patient registry: No

Groups and cohorts

Single group prospective treatment
Drug: Budesonide, Formoterol Fumarate Dihydrate

Interventions

DrugBudesonide, Formoterol Fumarate Dihydrate
Also known as: DuoResp® Spiromax®

What researchers measure

Primary outcomes

Patient Satisfaction and Preference Questionnaire (PASAPQ)
Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ
Time frame: 12 weeks
Practicability of the device
Investigation of practicability of the device for patients using checklist inhalation errors
Time frame: 12 weeks

Study locations

1 site

Teva Investigational Sites
Berlin, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02384577
Lead sponsor: Teva Pharma GmbH
Responsible party: Sponsor
First posted: Mar 10, 2015
Start date: Jul 2014
Primary completion: Mar 2016
Completion: Sep 2016
Last update: Nov 9, 2021

Study contacts

Teva Medical Expert, MD

study director · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment