Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)NCT01357460
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
A study testing Implantation of intrabronchial valves (IBV) (Spiration IBV) in people with Hereditary Emphysema (Alpha 1-antitrypsin Deficiency), run by Heidelberg University at 1 site in Germany.
Trial summary
Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
- What is being tested?
- Implantation of intrabronchial valves (IBV) (Spiration IBV)
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to 30 Dec 2014
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- alpha1 antitrypsin deficiency (< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
- heterogenous emphysema
Who cannot join
- homogenous emphysema
- significant bronchiectasis
- severe concomitant diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.
Read the detailed description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.
- Being tested
- Implantation of intrabronchial valves (IBV) (Spiration IBV)
- Keywords
- Emphysema, alpha1 antitrypsin deficiency, endoscopic lung volume reduction
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of intrabronchial valves (IBV) (Spiration IBV)Device
Also called Spiration IBV
In advanced emphysema due to alpha1 antitrypsin deficiency even optimum treatment including drugs, physical training and possibly oxygen therapy is unable to influence exercise dyspnoea and exercise capacity.Implantation of intrabronchial valves in the most destroyed and hyperinflated lung lobe can improve the elastic recoil of the small airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function.The one-way mechanism of these valves allows air to escape from the downstream lung segment without any influx of "new" air during inspiration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
Measured: 3 months
Secondary outcomes (4)
Number of major complications
Measured: 3 months
Evaluation of IBV migration rate
Measured: 3 months
Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)
Measured: 3 months
Average changes in 6-minute-walk-distance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completion24 Sep 2014
- Study completion30 Dec 2014
Why it stopped: difficult patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Daniela Gompelmann, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357460
- Sponsor's protocol ID
- Protocol D2.0 - 31.08.2010
- Status last verified
- Aug 2022
- First submitted
- 16 May 2011
- Last updated
- 30 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
- ClinicalTrials.gov ID
- NCT01357460
- Acronym / sponsor ID
- Protocol D2.0 - 31.08.2010
- Keywords
- Emphysema, alpha1 antitrypsin deficiency, endoscopic lung volume reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult patient recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- 24 Sep 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 20 May 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.
Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.
Detailed description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- alpha1 antitrypsin deficiency (< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
- heterogenous emphysema
Key exclusion criteria (4 listed)
- homogenous emphysema
- significant bronchiectasis
- severe concomitant diseases
- pregnancy
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 |
|---|---|---|
| Implantation of intrabronchial valves (IBV) (Spiration IBV)Also: Spiration IBVIn advanced emphysema due to alpha1 antitrypsin deficiency even optimum treatment including drugs, physical training and possibly oxygen therapy is unable to influence exercise dyspnoea and exercise capacity.Implantation of intrabronchial valves in the most destroyed and hyperinflated lung lobe can improve the elastic recoil of the small airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function.The one-way mechanism of these valves allows air to escape from the downstream lung segment without any influx of "new" air during inspiration. | Device | – |
Primary outcome
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
Time frame: 3 months
4 secondary outcomes
Number of major complications
Time frame: 3 months
Evaluation of IBV migration rate
Time frame: 3 months
Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)
Time frame: 3 months
Average changes in 6-minute-walk-distance
Time frame: 3 months
Results and safety
The study was stopped early (reason given: difficult patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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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.
Daniela Gompelmann, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of intrabronchial valves (IBV) (Spiration IBV) in people with Hereditary Emphysema (Alpha 1-antitrypsin Deficiency), run by Heidelberg University 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 3 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: stopped early, as of the sponsor's last update on 30 Aug 2022. 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 was stopped early (reason given: difficult patient recruitment). 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?
Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity) (time frame: 3 months). 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 30 Aug 2022.