Patient SatisfactionNCT02384577
Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment
An observational study of Patient Satisfaction, run by Teva Pharma GmbH at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Budesonide, Formoterol Fumarate Dihydrate
- How many people
- 4,034 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult asthma or COPD-patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Patient Satisfaction
- Being tested
- Budesonide, Formoterol Fumarate Dihydrate
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide, Formoterol Fumarate DihydrateDrug
Also called DuoResp® Spiromax®
| Study group | Role | What they receive |
|---|---|---|
| Single group prospective treatment | Not described Receives: Drug: Budesonide, Formoterol Fumarate Dihydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction and Preference Questionnaire (PASAPQ)
Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ
Measured: 12 weeks
Practicability of the device
Investigation of practicability of the device for patients using checklist inhalation errors
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384577
- Sponsor's protocol ID
- BFS-AS-40074
- Other IDs
- DRKS00006542
- Status last verified
- Nov 2021
- First submitted
- 4 Mar 2015
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02384577
- Acronym / sponsor ID
- BFS-AS-40074
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,034 participants (actual)
- Lead sponsor
- Teva Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group prospective treatment | – | Drug: Budesonide, Formoterol Fumarate Dihydrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult asthma or COPD-patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide, Formoterol Fumarate DihydrateAlso: DuoResp® Spiromax® | Drug | Single group prospective treatment |
Primary outcome
Patient Satisfaction and Preference Questionnaire (PASAPQ)
Time frame: 12 weeks
Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ
Practicability of the device
Time frame: 12 weeks
Investigation of practicability of the device for patients using checklist inhalation errors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction, run by Teva Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction and Preference Questionnaire (PASAPQ) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.