Chronic Pulmonary Obstructive DiseaseNCT01449175

A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

An observational study of Chronic Pulmonary Obstructive Disease and Emphysema, run by Aeris Therapeutics at 8 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Pulmonary Obstructive Disease, Emphysema
How many people: 54 participants
Where: 8 sitesin 4 countries
Study dates: Jan 2011to Nov 2013
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients participating in the Registry Study must have been enrolled in either Group 4 (homogeneous emphysema) or Group 5 (heterogeneous emphysema) of Aeris' Investigational Study 03-C08-003PLV and completed 48 week follow-up in the AeriSeal post market follow-up Continuation Study (03-C10-001PLV).

Who may be able to join

Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

Who cannot join

None listed.

Trial locations and contacts

8 sites in 4 countries.

Country

City, postcode or hospital

8 sites in 4 countries

Germany4 sites

Zentralklinik Bad Berka GmbH
Bad Berka, D-99437
Thoraxklinik Heidelberg
Heidelberg, D-69126
LungenKlinik Hemer
Hemer, D-58675
LMU Medizinische Klinik und Poliklinik Klinikum Großhadern
München, D-81377

Other trials in Germany

Israel2 sites

Soroka Medical Center
Beer Sheeva, 84101
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100

Other trials in Israel

Austria1 site

Otto Wagner Spital Wien
Wein, A-1140

Other trials in Austria

France1 site

Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
Nice, 06002 Cedex 1

Other trials in France

About this study

Read the detailed description

Conditions: Chronic Pulmonary Obstructive Disease, Emphysema
Keywords: AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction (PLVR), biologic lung volume reduction (BLVR), heterogeneous, homogeneous, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Emphysema, Respiratory Aspiration, Respiratory Tract Diseases, Lung Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in number of Serious Adverse Events (SAE)
Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety
Measured: Weeks 48, 96, 120, 144 following treatment

Secondary outcomes (5)

Change in Vital Signs
Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs
Measured: weeks 48, 96, 120, 144 following treatment
Change in Oxygen (O2) Use
Change in amount of O2 used (at rest, with activity, during sleep) in weeks 48, 96, 120 and 144 from baseline.
Measured: Weeks 48, 96, 120, 144 following treatment
Change in medications
Change in medication regiment in weeks 48, 96, 120 and 144 from baseline.
Measured: week 48, 96, 120, 144 following treatment
Change in Pulmonary Function Tests (PFT)
Change in PFT (Spirometry, Diffusing Capacity, Plethysmograpy) in weeks 48, 96, 120 and 144 from baseline
Measured: Weeks 48, 96, 120, 144 following treatment
Change in notable radiology results
Change in notable radiology results (infiltrates, mass lesions, pleural abnormalities) from baseline in weeks 48, 96, 120 and 144.
Measured: weeks 48, 96, 120, 144 following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Nov 2013

First posted10 Oct 2011 (estimated)
Study startJan 2011
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Pulmonary Obstructive DiseaseStudies 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: Cohort
Time perspective: Prospective
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01449175
Sponsor's protocol ID: 03-C11-001PLV
Status last verified: Nov 2013
First submitted: 19 Apr 2011
Last updated: 14 Nov 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Pulmonary Obstructive Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
ClinicalTrials.gov ID: NCT01449175
Acronym / sponsor ID: 03-C11-001PLV
Conditions: Chronic Pulmonary Obstructive Disease, Emphysema
Keywords: AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction (PLVR), biologic lung volume reduction (BLVR)
Study type: Observational
Recruitment status: Terminated
Enrolment: 54 participants (estimated)
Lead sponsor: Aeris TherapeuticsIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 10 Oct 2011 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients participating in the Registry Study must have been enrolled in either Group 4 (homogeneous emphysema) or Group 5 (heterogeneous emphysema) of Aeris' Investigational Study 03-C08-003PLV and completed 48 week follow-up in the AeriSeal post market follow-up Continuation Study (03-C10-001PLV).

Key inclusion criteria (1 listed)

Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

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.

Primary outcome

Change in number of Serious Adverse Events (SAE)
Time frame: Weeks 48, 96, 120, 144 following treatment
Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety

5 secondary outcomes

Change in Vital Signs
Time frame: weeks 48, 96, 120, 144 following treatment
Change in Oxygen (O2) Use
Time frame: Weeks 48, 96, 120, 144 following treatment
Change in medications
Time frame: week 48, 96, 120, 144 following treatment
Change in Pulmonary Function Tests (PFT)
Time frame: Weeks 48, 96, 120, 144 following treatment
Change in notable radiology results
Time frame: weeks 48, 96, 120, 144 following treatment

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.

Related trials for Chronic Pulmonary Obstructive Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

8 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pulmonary Obstructive Disease and Emphysema, run by Aeris Therapeutics at 8 sites in 4 countries.

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 1 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: stopped early, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Israel, Austria, France. 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 was stopped early. Results are not available in the source record.

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?

Change in number of Serious Adverse Events (SAE) (time frame: Weeks 48, 96, 120, 144 following treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01449175.

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 14 Nov 2013.