Pulmonary Disease, Chronic ObstructiveNCT02244216
Postmarketing Surveillance Study of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Berotec® N 100 µg Metered-dose Inhaler
- How many people
- 2,914 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Jun 2000
- 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: Patinet with chronic obstructive respiratory tract disease recruited at general practitioners, pneumologists, internists
Who may be able to join
- Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler
Who cannot join
- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler
About this study
Official title: Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Berotec® N 100 µg Metered-dose 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.
Berotec® N 100 µg Metered-dose InhalerDrug
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Respiratory Tract Disease | Not described Receives: Drug: Berotec® N 100 µg Metered-dose Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
Measured: After 3 weeks of first drug administration
Secondary outcomes (8)
Investigator assessment of efficacy on a 4-point scale
Measured: Up to 3 weeks after first drug administration
Patient assessment of efficacy on a 4-point scale
Measured: Up to 3 weeks after first drug administration
Patient assessment of tolerability on a 4-point scale
Measured: Up to 3 weeks after first drug administration
Investigator comparative overall assessment on a 4-point scale
Measured: After 3 weeks of first drug administration
Number of patients with adverse drug reactions
Measured: Up to 3 weeks after first drug administration
Number of patients who changed the concomitant medication
Measured: Up to 3 weeks after first drug administration
Number of patients who continued treatment
Measured: Up to 3 weeks after first drug administration
Number of patients who premature withdrew from the treatment
Measured: Up to 3 weeks after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startApr 2000
- Primary completionJun 2000
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
- 2,914 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
- NCT02244216
- Sponsor's protocol ID
- 260.3178
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
- ClinicalTrials.gov ID
- NCT02244216
- Acronym / sponsor ID
- 260.3178
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,914 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Jun 2000 (actual)
- First posted
- 19 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.
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Respiratory Tract Disease | – | Drug: Berotec® N 100 µg Metered-dose Inhaler |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patinet with chronic obstructive respiratory tract disease recruited at general practitioners, pneumologists, internists
Key inclusion criteria (1 listed)
- Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler
Key exclusion criteria (1 listed)
- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg 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 |
|---|---|---|
| Berotec® N 100 µg Metered-dose Inhaler | Drug | Chronic Obstructive Respiratory Tract Disease |
Primary outcome
Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg
Time frame: After 3 weeks of first drug administration
8 secondary outcomes
Investigator assessment of efficacy on a 4-point scale
Time frame: Up to 3 weeks after first drug administration
Patient assessment of efficacy on a 4-point scale
Time frame: Up to 3 weeks after first drug administration
Patient assessment of tolerability on a 4-point scale
Time frame: Up to 3 weeks after first drug administration
Investigator comparative overall assessment on a 4-point scale
Time frame: After 3 weeks of first drug administration
Number of patients with adverse drug reactions
Time frame: Up to 3 weeks after first drug administration
Number of patients who changed the concomitant medication
Time frame: Up to 3 weeks after first drug administration
Number of patients who continued treatment
Time frame: Up to 3 weeks after first drug administration
Number of patients who premature withdrew from the treatment
Time frame: Up to 3 weeks after first drug administration
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 19 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 1 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 19 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 the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg (time frame: After 3 weeks of first drug administration). 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 19 Sep 2014.