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

NCT02384577 | Completed

• 2 other identifiers: BFS-AS-40074DRKS00006542
• Study Type: observational
• Target: 4,034
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single group prospective treatment

Drug: Budesonide, Formoterol Fumarate Dihydrate

Interventions

Budesonide, Formoterol Fumarate Dihydrate DRUG

Also known as: DuoResp® Spiromax®

Single group prospective treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult asthma or COPD-patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Pharma GmbH: lead

Study Sites (1)

Teva Investigational Sites

Berlin, Germany

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

DE (1)