Lung Volume Reduction Via Coils in Patients With COPD

NCT02246569 | Unknown

• 1 other identifier: 14-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the insertion of the coils distended lung sections shrink so that healthy parts can expand. In the present study investigators intend to examine, whether the insertion of the coils improves diaphragm function and force of the breathing muscles. Investigators hypothesize that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease (COPD); endoscopic lung volume reduction; RePneu®Coils; physical capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• breathing strength

  Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure

  Change of breathing strength 3 (respectively 9) months after the bronchoscopy

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

patients with severe COPD (GOLD stage III or IV)

You may qualify if:

• bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu Coil implantation at the discretion of the treating physicians
• homogeneous or heterogeneous emphysema
• previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)
• nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) \< 2%
• FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation
• total lung capacity (TLC) ≥ 100% of reference value
• residual volume (RV) ≥ 175% of reference value
• patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.
• signed Informed Consent
• understanding of the nature, significance and implications of the study
• ability to understand and follow instructions of the study stuff

You may not qualify if:

• echo-cardiographic right ventricular pressure (PAPsys) \> 50 mmHg
• indication for a permanent anticoagulation therapy (besides ASS)
• pulmonal cachexia
• pregnancy and lactating
• permanent treatment with \> 20 mg Prednison per day
• hospitalisation due to a COPD-exacerbation in the last 3 months
• \> 3 steroid-treated exacerbations in the last year
• Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
• severe diffusion impairment (DLCO \< 20%)

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Univerity Hospital MK1

Aachen, 52074, Germany

RECRUITING

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

• Michael Dreher, Univ.-Prof.

  RWTH University Hospital MK1

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dreher, Univ.-Prof.

CONTACT

+49241 80 88763; mdreher@ukaachen.de

Tobias Müller, PD Dr.med.

CONTACT

+49241 80 88763; tobmueller@ukaachen.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 22, 2014
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

DE (1)