Pulmonary Disease, Chronic ObstructiveNCT02238197
Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice Read more about this study
- Who is it for?
- Ages 13 to 89 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Atrovent® Inhalation Solution
- How many people
- 477 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Oct 2001
- 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 13 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic obstructive airways disease recruited at pneumologists and internists
Who may be able to join
- Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary disease
- Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion
Who cannot join
- Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
- Patients who exhibited adverse drug reactions
About this study
Official title: Postmarketing Surveillance Study (as Per §67 (6) AMG [German Drug Law]) of Atrovent® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary Disease
To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Atrovent® Inhalation Solution
- 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.
Atrovent® Inhalation SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Not described Receives: Drug: Atrovent® Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total severity of the clinical picture rated on a 4-point scale
Measured: Up to 4 weeks after first study drug administration
Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile
Measured: up to 4 weeks after first study drug administration
Secondary outcomes (5)
Assessment of efficacy by investigator on a 4-point scale
Measured: Up to 4 weeks after first study drug administration
Assessment of efficacy by patient on a 4-point scale
Measured: Up to 4 weeks after first study drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: Up to 4 weeks after first study drug administration
Assessment of tolerability by patient on a 4-point scale
Measured: Up to 4 weeks after first study drug administration
Number of patients with adverse drug reactions
Measured: Up to 4 weeks after first study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startFeb 2001
- Primary completionOct 2001
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
- 477 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
- NCT02238197
- Sponsor's protocol ID
- 244.2500
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 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 Atrovent® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02238197
- Acronym / sponsor ID
- 244.2500
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Oct 2001 (actual)
- First posted
- 12 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.
To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | Drug: Atrovent® Inhalation Solution |
Who may qualify
- Ages
- 13 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic obstructive airways disease recruited at pneumologists and internists
Key inclusion criteria (2 listed)
- Patients of both genders, older than 40 years,who suffer from chronic obstructive Pulmonary disease
- Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion
Key exclusion criteria (2 listed)
- Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
- Patients who exhibited adverse drug reactions
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 |
|---|---|---|
| Atrovent® Inhalation Solution | Drug | Chronic Obstructive Pulmonary Disease |
Primary outcome
Change in total severity of the clinical picture rated on a 4-point scale
Time frame: Up to 4 weeks after first study drug administration
Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile
Time frame: up to 4 weeks after first study drug administration
5 secondary outcomes
Assessment of efficacy by investigator on a 4-point scale
Time frame: Up to 4 weeks after first study drug administration
Assessment of efficacy by patient on a 4-point scale
Time frame: Up to 4 weeks after first study drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: Up to 4 weeks after first study drug administration
Assessment of tolerability by patient on a 4-point scale
Time frame: Up to 4 weeks after first study drug administration
Number of patients with adverse drug reactions
Time frame: Up to 4 weeks after first study 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 12 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 2 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 12 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 total severity of the clinical picture rated on a 4-point scale (time frame: Up to 4 weeks after first study drug administration). 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 12 Sep 2014.