Study to Evaluate Satisfaction and Usability of DuoResp®... | NCT02384577

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

NCT02384577

Sponsor

Teva Pharma GmbH

Status

Completed

Last Update Posted

Nov 9, 2021Actual

Enrollment

4,034Actual

Phase

Not provided

Conditions

Patient Satisfaction

Interventions

Budesonide, Formoterol Fumarate Dihydrate

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DRKS00006542	Registry Identifier	German Clinical Trials Register

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Mar 4, 2015

First Submission Date that Met QC Criteria

Mar 9, 2015

First Posted Date

Mar 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2021

Last Update Posted Date

Nov 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,034Actual

Label	Type	Description	Intervention Names
Single group prospective treatment			Drug: Budesonide, Formoterol Fumarate Dihydrate

Name	Type	Description	Arm Group Labels	Other Names
Budesonide, Formoterol Fumarate Dihydrate	Drug		Single group prospective treatment	DuoResp® Spiromax®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult asthma or COPD-patients

Sampling Method

Non-Probability Sample

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473