Pulmonary Disease, Chronic ObstructiveNCT02231359
Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Berodual® Respimat® solution for inhalation
- How many people
- 2,006 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Sep 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology in practice
Who may be able to join
- Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
- Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included
Who cannot join
- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
About this study
Official title: Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Berodual® Respimat® solution for inhalation
- 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® solution for inhalationDrug
| Study group | Role | What they receive |
|---|---|---|
| chronic obstructive airways disease patients | Not described Receives: Drug: Berodual® Respimat® solution for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall severity of clinical picture rated on 3-point scale
Measured: up to 12 weeks
Change in breathlessness rated on a 4-point scale
Measured: up to 12 weeks
Change in restriction of activity due to breathlessness rated on a 4-point scale
Measured: up to 12 weeks
Change in number of awakening due to nocturnal breathlessness rated on 4-point scale
Measured: up to 12 weeks
Global assessment of efficacy by the patients rated on 5-point scale
Measured: after 4, 8 and 12 weeks
Global assessment of efficacy by the investigator rated on 5-point scale
Measured: after 4, 8 and 12 weeks
Number of patients with adverse drug reactions
Measured: up to 12 weeks
Assessment of tolerability on a 5-point scale
Measured: after 4, 8 and 12 weeks
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 startJan 2004
- Primary completionSep 2004
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
- 2,006 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
- NCT02231359
- Sponsor's protocol ID
- 215.1363
- 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® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease
- ClinicalTrials.gov ID
- NCT02231359
- Acronym / sponsor ID
- 215.1363
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,006 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Sep 2004 (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.
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic obstructive airways disease patients | – | Drug: Berodual® Respimat® solution for inhalation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology in practice
Key inclusion criteria (2 listed)
- Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms
- Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included
Key exclusion criteria (1 listed)
- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
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® solution for inhalation | Drug | chronic obstructive airways disease patients |
Primary outcome
Change in overall severity of clinical picture rated on 3-point scale
Time frame: up to 12 weeks
Change in breathlessness rated on a 4-point scale
Time frame: up to 12 weeks
Change in restriction of activity due to breathlessness rated on a 4-point scale
Time frame: up to 12 weeks
Change in number of awakening due to nocturnal breathlessness rated on 4-point scale
Time frame: up to 12 weeks
Global assessment of efficacy by the patients rated on 5-point scale
Time frame: after 4, 8 and 12 weeks
Global assessment of efficacy by the investigator rated on 5-point scale
Time frame: after 4, 8 and 12 weeks
Number of patients with adverse drug reactions
Time frame: up to 12 weeks
Assessment of tolerability on a 5-point scale
Time frame: after 4, 8 and 12 weeks
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.
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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.
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 2 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?
Change in overall severity of clinical picture rated on 3-point scale (time frame: up to 12 weeks). The study lists 8 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.