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

NCT03287921 | Completed DMC FDA Drug

• 1 other identifier: MBW-hyperinflation
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

pulmonary care; COPD; small airway disease; hyperinflation

Outcome Measures

Primary Outcomes (3)

• residual volume

  change in residual volume from baseline

  8 weeks

• D5-20

  change in frequency dependence of resistance from baseline

  8 weeks

• LCI

  change in lung clearance index from baseline

  8 weeks

Secondary Outcomes (3)

• tpeak

  8 weeks

• IC

  8 weeks

• SGRQ

  8 weeks

Study Arms (2)

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

mono bronchodilatation DRUG

within indication according to current GOLD recommendation

Also known as: bronchodilator monotherapy

dual bronchodilatation; mono bronchodilatation

dual bronchodilatation DRUG

within indication according to current GOLD recommendation

Also known as: dual bronchodilator therapy

dual bronchodilatation; mono bronchodilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

University Medical Center Mannheim

Mannheim, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederik Trinkmann, MD

  University Medical Center Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: September 19, 2017
• Study Start: October 2, 2017
• Primary Completion: November 30, 2018
• Study Completion: April 11, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)