COPDNCT03287921
Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD
An observational study of COPD, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. Hyperinflation and affection of the small airways are two components that are not represented in current diagnostic concepts and may relate to early stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- mono bronchodilatation and dual bronchodilatation
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2017to 11 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patients and out-patients with known or firstly diagnosed COPD
Who may be able to join
- known or first diagnosis of COPD
- lung function testing consistent with hyperinflation or peripheral obstruction
- emphysema in imaging
- symptoms (dyspnea, cough, sputum) and risk factors (>= 10 pack years)
- indication for bronchodilator therapy
Who cannot join
- GOLD stages 3 and 4 (spirometric)
- indication for dual bronchodilator therapy, triple therapy or inhaled steroid
- contraindication for cardiopulmonary exercise testing
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. Hyperinflation and affection of the small airways are two components that are not represented in current diagnostic concepts and may relate to early stages of the disease. Moreover, optimal therapeutic interventions in patients with these distinct features remain unclear. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and initiating therapeutic strategies in early stage COPD within the GOLD recommendations.
- Conditions
- COPD
- Being tested
- mono bronchodilatation, dual bronchodilatation
- Keywords
- pulmonary care, COPD, small airway disease, hyperinflation
- 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.
mono bronchodilatationDrug
Also called bronchodilator monotherapy
within indication according to current GOLD recommendation
dual bronchodilatationDrug
Also called dual bronchodilator therapy
within indication according to current GOLD recommendation
| Study group | Role | What they receive |
|---|---|---|
| mono bronchodilatation | patients with COPD and features of hyperinflation and small airway disease Receives: Drug: mono bronchodilatation; Drug: dual bronchodilatation | |
| dual bronchodilatation | patients with COPD and features of hyperinflation and small airway disease Receives: Drug: mono bronchodilatation; Drug: dual bronchodilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual volume
change in residual volume from baseline
Measured: 8 weeks
D5-20
change in frequency dependence of resistance from baseline
Measured: 8 weeks
LCI
change in lung clearance index from baseline
Measured: 8 weeks
Secondary outcomes (3)
tpeak
increase in exercise duration from baseline
Measured: 8 weeks
IC
increase in inspiratory capacity (isotime and resting) from baseline
Measured: 8 weeks
SGRQ
improvement in St. George's Respiratory Questionaire from baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start2 Oct 2017
- Primary completion30 Nov 2018
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
- Investigators
- Frederik Trinkmann, MD, Principal investigator, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287921
- Sponsor's protocol ID
- MBW-hyperinflation
- Status last verified
- Mar 2020
- First submitted
- 17 Sep 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD
- ClinicalTrials.gov ID
- NCT03287921
- Acronym / sponsor ID
- MBW-hyperinflation
- Conditions
- COPD
- Keywords
- pulmonary care, COPD, small airway disease, hyperinflation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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.
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. Hyperinflation and affection of the small airways are two components that are not represented in current diagnostic concepts and may relate to early stages of the disease. Moreover, optimal therapeutic interventions in patients with these distinct features remain unclear. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and initiating therapeutic strategies in early stage COPD within the GOLD recommendations.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mono bronchodilatation | – | Drug: mono bronchodilatation, Drug: dual bronchodilatationpatients with COPD and features of hyperinflation and small airway disease |
| dual bronchodilatation | – | Drug: mono bronchodilatation, Drug: dual bronchodilatationpatients with COPD and features of hyperinflation and small airway disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients and out-patients with known or firstly diagnosed COPD
Key inclusion criteria (5 listed)
- known or first diagnosis of COPD
- lung function testing consistent with hyperinflation or peripheral obstruction
- emphysema in imaging
- symptoms (dyspnea, cough, sputum) and risk factors (>= 10 pack years)
- indication for bronchodilator therapy
Key exclusion criteria (4 listed)
- GOLD stages 3 and 4 (spirometric)
- indication for dual bronchodilator therapy, triple therapy or inhaled steroid
- contraindication for cardiopulmonary exercise testing
- unwilling to participate
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 |
|---|---|---|
| mono bronchodilatationAlso: bronchodilator monotherapywithin indication according to current GOLD recommendation | Drug | dual bronchodilatation, mono bronchodilatation |
| dual bronchodilatationAlso: dual bronchodilator therapywithin indication according to current GOLD recommendation | Drug | dual bronchodilatation, mono bronchodilatation |
Primary outcome
residual volume
Time frame: 8 weeks
change in residual volume from baseline
D5-20
Time frame: 8 weeks
change in frequency dependence of resistance from baseline
LCI
Time frame: 8 weeks
change in lung clearance index from baseline
3 secondary outcomes
tpeak
Time frame: 8 weeks
IC
Time frame: 8 weeks
SGRQ
Time frame: 8 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 31 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Frederik Trinkmann, MD principal investigator
University Medical Center Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 5 inclusion and 4 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
residual volume (time frame: 8 weeks). The study lists 3 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 31 Mar 2020.