Lung TransplantationEarly Phase 1NCT00378677
Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
A Early Phase 1 study testing Cyclosporine A dry powder inhalation (Drug) in people with Lung Transplantation and Bronchiolitis Obliterans, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, Bronchiolitis Obliterans
- What is being tested?
- Cyclosporine A dry powder inhalation (Drug)
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2007to not given
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Primary lung transplant
- Tacrolimus as maintenance therapy
- Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1<80% of baseline
- At least 3 months after last usual BOS intervention
- Declining FEV1 after last usual BOS intervention
Who cannot join
- Cyclosporine as maintenance therapy
- Bronchiolitis Obliterans Syndrome 0: FEV1>80%
- Renal failure: Glomerular Filtration Rate < 30 ml/min
- Chronic airway infections
- Clinical stability
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Wim Van Der Bij, MD, PhD contact
Huib Kerstjens, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Wim Van Der Bij, Md, PhD
About this study
Official title: Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.
Read the detailed description
Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndrome, BOS) a rejection risc remains. To effectively treat BOS high doses of calcineurin inhibitors are necessary. On the other hand these high doses lead te serious side effects. The search for a balance between effectiveness and side effects leads to dose adjustments. Ultimately, chronic rejection is unstoppable.
In order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. The only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. Indeed, this has been extensively investigated at the University of Pittsburgh (lead investigator Iacono).
The intervention in the Pittsburgh trials existed of nebulization of Cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable.
The investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine A. The effectiveness is measured by comparing the Forced Expiratory Volume in 1 second (FEV1) before and after the intervention.
- Conditions
- Lung Transplantation, Bronchiolitis Obliterans
- Being tested
- Cyclosporine A dry powder inhalation (Drug)
- Keywords
- Powder inhalation, Side effects, Nephrotoxicity, Calcineurin inhibitor, Bronchiolitis obliterans syndrome, Forced Expiratory Volume
- Medical subject headings
- Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine A dry powder inhalation (Drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in 1 second before and after intervention
Amount of lung deposition of cyclosporine A
Systemic uptake of Cyclosporine A
Secondary outcomes (1)
Kidney function (GFR and serum creat)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Gerrit Zijlstra, Pharmacist, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378677
- Sponsor's protocol ID
- CSA-DPI
- Status last verified
- Feb 2007
- First submitted
- 20 Sep 2006
- Last updated
- 7 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
- ClinicalTrials.gov ID
- NCT00378677
- Acronym / sponsor ID
- CSA-DPI
- Conditions
- Lung Transplantation, Bronchiolitis Obliterans
- Keywords
- Powder inhalation, Side effects, Nephrotoxicity, Calcineurin inhibitor, Bronchiolitis obliterans syndrome, Forced Expiratory Volume
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Feb 2007
- First posted
- 21 Sep 2006 (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 investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.
Detailed description
Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndrome, BOS) a rejection risc remains. To effectively treat BOS high doses of calcineurin inhibitors are necessary. On the other hand these high doses lead te serious side effects. The search for a balance between effectiveness and side effects leads to dose adjustments. Ultimately, chronic rejection is unstoppable.
In order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. The only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. Indeed, this has been extensively investigated at the University of Pittsburgh (lead investigator Iacono).
The intervention in the Pittsburgh trials existed of nebulization of Cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable.
The investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine A. The effectiveness is measured by comparing the Forced Expiratory Volume in 1 second (FEV1) before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- Primary lung transplant
- Tacrolimus as maintenance therapy
- Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1<80% of baseline
- At least 3 months after last usual BOS intervention
Key exclusion criteria (6 listed)
- Cyclosporine as maintenance therapy
- Bronchiolitis Obliterans Syndrome 0: FEV1>80%
- Renal failure: Glomerular Filtration Rate < 30 ml/min
- Chronic airway infections
- Clinical stability
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 |
|---|---|---|
| Cyclosporine A dry powder inhalation (Drug) | Drug | – |
Primary outcome
Change in Forced Expiratory Volume in 1 second before and after intervention
Amount of lung deposition of cyclosporine A
Systemic uptake of Cyclosporine A
1 secondary outcome
Kidney function (GFR and serum creat)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2007.
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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.
Wim Van Der Bij, MD, PhD contact
Huib Kerstjens, MD, PhD contact
Gerrit Zijlstra, Pharmacist principal investigator
University of Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cyclosporine A dry powder inhalation (Drug) in people with Lung Transplantation and Bronchiolitis Obliterans, run by University Medical Center Groningen at 1 site in Netherlands.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Feb 2007. 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 Netherlands. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim Van Der Bij, MD, PhD (+31 50 3616161), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 second before and after intervention. The study lists 3 primary outcomes in all. 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 7 Feb 2007.