Pulmonary Disease, Chronic ObstructiveNCT02176564
Inhaled Bronchodilator Association and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- inhaled bronchodilator
- How many people
- 2,639 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to Oct 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: Patients with COPD
Who may be able to join
- Diagnosis of COPD confirmed by Pulmonary Function Test (PFTs)
- Recent treatment with a free or fixed association of inhaled bronchodilators
Who cannot join
None listed.
About this study
Official title: COPD, Inhaled Bronchodilators Association, and Quality of Life
A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- inhaled bronchodilator
- 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.
inhaled bronchodilatorDrug
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease | Patients with COPD treated with inhaled bronchodilators Receives: Drug: inhaled bronchodilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of health-related quality of life (Short-Form Health Survey)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 1999
- Primary completionOct 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
- 2,639 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
- NCT02176564
- Sponsor's protocol ID
- 1012.40
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD, Inhaled Bronchodilators Association, and Quality of Life
- ClinicalTrials.gov ID
- NCT02176564
- Acronym / sponsor ID
- 1012.40
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,639 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Oct 2000 (actual)
- First posted
- 27 Jun 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.
A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease | – | Drug: inhaled bronchodilatorPatients with COPD treated with inhaled bronchodilators |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COPD
Key inclusion criteria (2 listed)
- Diagnosis of COPD confirmed by Pulmonary Function Test (PFTs)
- Recent treatment with a free or fixed association of inhaled bronchodilators
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| inhaled bronchodilator | Drug | Chronic obstructive pulmonary disease |
Primary outcome
Assessment of health-related quality of life (Short-Form Health Survey)
Time frame: 4 months
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 18 Jul 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 0 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 18 Jul 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?
Assessment of health-related quality of life (Short-Form Health Survey) (time frame: 4 months). 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 18 Jul 2014.