This trial has been completed.

Condition patient satisfaction
Treatment budesonide, formoterol fumarate dihydrate
Sponsor Teva Pharma GmbH
Start date July 2014
End date March 2016
Trial size 4034 participants
Trial identifier NCT02384577, BFS-AS-40074, DRKS00006542


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
budesonide, formoterol fumarate dihydrate DuoResp® Spiromax®

Primary Outcomes

Patient Satisfaction and Preference Questionnaire (PASAPQ)
time frame: 12 weeks
Practicability of the device
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multicenter, Open-label, Non-interventional Study (NIS) to Evaluate Patient's Satisfaction and Preference, the Usability of DuoResp® SPIROMAX® and the Impact on Clinical Effects, in the Daily Routine of Asthma and COPD Treatment
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.