Bronchiolitis ObliteransPhase 3NCT01439958
Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)
A Phase 3 study testing Inhalation in people with Bronchiolitis Obliterans, run by Pari Pharma GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Dec 2014
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has completed the L-CsA clinical trial 12011.201
- Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study
- Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study
- Estimated life expectancy > 6 months
- Capable of self-administration of medications
- Patient has stable creatinine levels
Who cannot join
- Patients with ongoing irreversible L-CsA related serious adverse events
- Patients with known hypersensitivity for ciclosporin A
- Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
- Patient receives mechanical ventilation
- Patients underwent pulmonary re-transplantation
- Patient is a pregnant or breast-feeding woman
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- Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
- Patient receives any systemic or topical Rosuvastatin
- Patient has been previously enrolled in this study
- Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
- Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
- Patient is not eligible to continue IMP inhalation according to the Investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation Therapy
The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
Read the detailed description
This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.
Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- Inhalation
- Keywords
- Inhalation, Lung Transplantation, Cyclosporine
- Medical subject headings
- Bronchiolitis Obliterans, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InhalationDrug
Also called aerosolized liposomal CsA
Twice daily inhalation for a maximum of three years.
| Study group | Role | What they receive |
|---|---|---|
| L-CsA | Experimental | Twice daily inhalation of L-CsA Receives: Drug: Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.
Measured: 3 years
Secondary outcomes (1)
Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201
Efficacy will be assessed mainly for the following efficacy endpoints:
- BOS-free survival
- Incidence of BOS
- Pulmonary function
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionDec 2014
Why it stopped: Core study 12011.201 was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pari Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Neurohr, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439958
- Sponsor's protocol ID
- 12011.203
- Other IDs
- 2011-004304-38
- Status last verified
- Apr 2015
- First submitted
- 22 Sep 2011
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation Therapy
- ClinicalTrials.gov ID
- NCT01439958
- Acronym / sponsor ID
- 12011.203
- Conditions
- Bronchiolitis Obliterans
- Keywords
- Inhalation, Lung Transplantation, Cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Core study 12011.201 was terminated.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pari Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Sep 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.
The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
Detailed description
This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.
Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-CsA | Experimental | Drug: InhalationTwice daily inhalation of L-CsA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has completed the L-CsA clinical trial 12011.201
- Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study
- Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study
- Estimated life expectancy > 6 months
- Capable of self-administration of medications
Key exclusion criteria (12 listed)
- Patients with ongoing irreversible L-CsA related serious adverse events
- Patients with known hypersensitivity for ciclosporin A
- Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
- Patient receives mechanical ventilation
- Patients underwent pulmonary re-transplantation
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 |
|---|---|---|
| InhalationAlso: aerosolized liposomal CsATwice daily inhalation for a maximum of three years. | Drug | L-CsA |
Primary outcome
Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
Time frame: 3 years
Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.
1 secondary outcome
Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Core study 12011.201 was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Claus Neurohr, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhalation in people with Bronchiolitis Obliterans, run by Pari Pharma GmbH 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 6 inclusion and 12 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 Apr 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Core study 12011.201 was terminated.). 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?
Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) (time frame: 3 years). 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 14 Apr 2015.