Pulmonary Disease, Chronic ObstructiveNCT02231437
Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Berodual®
- How many people
- 3,488 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Nov 1999
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: general practitioners, pneumologists and internists
Who may be able to join
- Patients with diagnosis of Chronic obstructive respiratory tract disease
- Patients of either sex, including children over 6 years
Who cannot join
- Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
About this study
Official title: Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Berodual®
- 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®Drug
| Study group | Role | What they receive |
|---|---|---|
| chronic obstructive respiratory tract disease patients | Not described Receives: Drug: Berodual® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall severity of the clinical picture rated on a 4-point scale
Measured: after 3 and 6 weeks
Secondary outcomes (9)
Changes in dyspnea and/or asthma attacks rated on a 4-point scale
Measured: after 3 and 6 weeks
Number of dyspnea episodes rated on a 4-point scale
Measured: after 3 and 6 weeks
Number of awakenings due to night-time dyspnea rated on a 4-point scale
Measured: after 3 and 6 weeks
Assessment of morning coughing with expectoration on a 4-point scale
Measured: after 3 and 6 weeks
Assessment of tolerability on a 4-point scale
Measured: after 3 and 6 weeks
Number of patients with adverse drug reactions
Measured: up to 6 weeks
Changes in pathological auscultation findings rated on a 3-point scale
Measured: after 3 and 6 weeks
Changes in concomitant medication
Measured: up to 6 weeks
Assessment of efficacy on a 4-point scale
Measured: after 3 and 6 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 1999
- Primary completionNov 1999
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
- 3,488 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
- NCT02231437
- Sponsor's protocol ID
- 215.1352
- Status last verified
- Sep 2014
- First submitted
- 1 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
- Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
- ClinicalTrials.gov ID
- NCT02231437
- Acronym / sponsor ID
- 215.1352
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,488 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Nov 1999 (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.
The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic obstructive respiratory tract disease patients | – | Drug: Berodual® |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- general practitioners, pneumologists and internists
Key inclusion criteria (2 listed)
- Patients with diagnosis of Chronic obstructive respiratory tract disease
- Patients of either sex, including children over 6 years
Key exclusion criteria (1 listed)
- Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
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® | Drug | chronic obstructive respiratory tract disease patients |
Primary outcome
Overall severity of the clinical picture rated on a 4-point scale
Time frame: after 3 and 6 weeks
9 secondary outcomes
Changes in dyspnea and/or asthma attacks rated on a 4-point scale
Time frame: after 3 and 6 weeks
Number of dyspnea episodes rated on a 4-point scale
Time frame: after 3 and 6 weeks
Number of awakenings due to night-time dyspnea rated on a 4-point scale
Time frame: after 3 and 6 weeks
Assessment of morning coughing with expectoration on a 4-point scale
Time frame: after 3 and 6 weeks
Assessment of tolerability on a 4-point scale
Time frame: after 3 and 6 weeks
Number of patients with adverse drug reactions
Time frame: up to 6 weeks
Changes in pathological auscultation findings rated on a 3-point scale
Time frame: after 3 and 6 weeks
Changes in concomitant medication
Time frame: up to 6 weeks
Assessment of efficacy on a 4-point scale
Time frame: after 3 and 6 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?
Overall severity of the clinical picture rated on a 4-point scale (time frame: after 3 and 6 weeks). 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.