Pulmonary Disease, Chronic ObstructiveNCT02231346
Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Comparison to a Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat® Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Berodual® Respimat® - inhaler
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Apr 2006
- 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: Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists in practice
Who may be able to join
- Male and female patients aged at least 18 years
- Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
- During the PMS the Diskus® therapy is to be continued
Who cannot join
- Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)
About this study
Official title: Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler
New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Berodual® Respimat® - inhaler
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berodual® Respimat® - inhalerDrug
| Study group | Role | What they receive |
|---|---|---|
| chronic obstructive pulmonary disease patients | Not described Receives: Drug: Berodual® Respimat® - inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 4 weeks
Number of patients who prematurely discontinued therapy with Berodual® Respimat®
Measured: up to 4 weeks
Secondary outcomes (2)
Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler
by means of a patient satisfaction and preference questionnaire (PASAPQ)
Measured: up to 4 weeks
Assessment of patient satisfaction with regard to handling of Diskus® inhaler
by means of patient satisfaction and preference questionnaire (PASAPQ)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startOct 2005
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231346
- Sponsor's protocol ID
- 215.1366
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction in Comparison to a Powder Inhaler
- ClinicalTrials.gov ID
- NCT02231346
- Acronym / sponsor ID
- 215.1366
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Apr 2006 (actual)
- First posted
- 4 Sep 2014 (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.
New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® compared to a powder inhaler in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic obstructive pulmonary disease patients | – | Drug: Berodual® Respimat® - inhaler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists in practice
Key inclusion criteria (3 listed)
- Male and female patients aged at least 18 years
- Patients who are suffering from symptoms of a chronic obstructive lung disease (COLD) can be included in the PMS. To reduce influences caused by the use of a variety of different powder inhaler, only patients who are already regularly using Diskus® powder inhaler should be included, as the Diskus® as well as the Berodual® Respimat® are multiple dose devices
- During the PMS the Diskus® therapy is to be continued
Key exclusion criteria (1 listed)
- Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)
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 |
|---|---|---|
| Berodual® Respimat® - inhaler | Drug | chronic obstructive pulmonary disease patients |
Primary outcome
Number of patients with adverse events
Time frame: up to 4 weeks
Number of patients who prematurely discontinued therapy with Berodual® Respimat®
Time frame: up to 4 weeks
2 secondary outcomes
Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler
Time frame: up to 4 weeks
Assessment of patient satisfaction with regard to handling of Diskus® inhaler
Time frame: Baseline
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 4 Sep 2014.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 3 inclusion and 1 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with adverse events (time frame: up to 4 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 4 Sep 2014.