CClinicalTrials.gg
Sign In
CompletedNCT03287921Updated Mar 31, 2020

Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD

An observational study in COPD, sponsored by Universitätsmedizin Mannheim. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by Universitätsmedizin Mannheim · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • COPD

Keywords

  • pulmonary care
  • COPD
  • small airway disease
  • hyperinflation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

hospitalized patients and out-patients with known or firstly diagnosed COPD

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • GOLD stages 3 and 4 (spirometric)
  • indication for dual bronchodilator therapy, triple therapy or inhaled steroid
  • contraindication for cardiopulmonary exercise testing
  • unwilling to participate
04

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • mono bronchodilatation

    patients with COPD and features of hyperinflation and small airway disease

    Drug: mono bronchodilatation · Drug: dual bronchodilatation

  • dual bronchodilatation

    patients with COPD and features of hyperinflation and small airway disease

    Drug: mono bronchodilatation · Drug: dual bronchodilatation

Interventions

  • Drugmono bronchodilatation

    within indication according to current GOLD recommendation

    Also known as: bronchodilator monotherapy

  • Drugdual bronchodilatation

    within indication according to current GOLD recommendation

    Also known as: dual bronchodilator therapy

05

What researchers measure

Primary outcomes

  1. residual volume

    change in residual volume from baseline

    Time frame: 8 weeks

  2. D5-20

    change in frequency dependence of resistance from baseline

    Time frame: 8 weeks

  3. LCI

    change in lung clearance index from baseline

    Time frame: 8 weeks

Secondary outcomes

  1. tpeak

    increase in exercise duration from baseline

    Time frame: 8 weeks

  2. IC

    increase in inspiratory capacity (isotime and resting) from baseline

    Time frame: 8 weeks

  3. SGRQ

    improvement in St. George's Respiratory Questionaire from baseline

    Time frame: 8 weeks

06

Study locations

1 site
  • University Medical Center Mannheim
    Mannheim, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03287921
Lead sponsor
Universitätsmedizin Mannheim
Responsible party
Dr. Frederik Trinkmann (Principal Investigator, Universitätsmedizin Mannheim) — Principal investigator
First posted
Sep 19, 2017
Start date
Oct 2, 2017
Primary completion
Nov 30, 2018
Completion
Apr 11, 2019
Last update
Mar 31, 2020

Study contacts

Frederik Trinkmann, MD
principal investigator · University Medical Center Mannheim

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pulmonary Disease, Chronic Obstructive→

Other studies from this sponsor

Universitätsmedizin Mannheim

Start the discussion