Cystic FibrosisPhase 2NCT01991028
A Study to Investigate Lung Deposition of Radiolabelled OligoG
A Phase 2 study testing Radiolabelled OligoG CF-5/20 DPI and Radiolabelled OligoG CF-5/20 6% Solution in people with Cystic Fibrosis, run by BDD Pharma Ltd at 1 site in United Kingdom.
Trial summary
OligoG is a new potential treatment which is being developed by AlgiPharma AS (a Norwegian-based company) with an aim to help people with cystic fibrosis in the future. OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to reduce mucus thickness and improve mucus clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Radiolabelled OligoG CF-5/20 DPI and Radiolabelled OligoG CF-5/20 6% Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Sep 2014
- Phase
- Phase 2
- 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
- Aged at least 18 years at screening. Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities.
- Male or female with a confirmed diagnosis of cystic fibrosis defined by:
- i.Clinical features consistent with the diagnosis of cystic fibrosis (Rosenstein et al., 1998); AND ii.Sweat chloride ≥ 60 mmol/L by pilocarpine iontophoresis; OR iii.Genotypic confirmation of 2 CF-causing mutations
- Positive microbiological finding of Pseudomonas aeruginosa (mucoid or nonmucoid) in expectorated sputum (and/or swab) documented within the last 24 months prior to screening. Negative finding is acceptable provided the proportion of patients enrolled with positive findings is at least 80%.
- At screening, FEV1 must be between 35 and 80% of the predicted normal value following adjustment for age, gender and height according to the Knudson equation (Knudson et al., 1983)
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- Clinically stable in the opinion of the referring physician at CF unit.
- Female subjects of child-bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. For the purpose of this study, acceptable contraception is defined as:
- i.Oral, injected or implanted hormonal methods or contraception; OR ii.Placement of an intrauterine device (IUD) or intrauterine system (IUS); OR iii.Barrier methods of contraception: condom or occlusive cap with spermicidal foam/gel/film/cream/suppository
Who cannot join
- On-going acute illness. Patients must not have needed an outpatient visit, hospitalisation or required any change in therapy for other pulmonary disease between screening and AV1.
- History of, or planned organ transplantation.
- Requirement for continuous (24 hour/day) oxygen supplementation.
- Concomitant administration of inhaled mannitol or hypertonic saline within 48 hours of Period 1, Day 1.
- Clinically significant abnormal findings on haematology or clinical chemistry. In addition, any value ≥ 3 x the upper limit of normal will exclude the patient from participating in the study.
- Unable to perform pulmonary function tests according to ATS criteria.
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- Pregnant or breast-feeding women.
- Participated in any interventional clinical trial within the 28 days prior to AV1.
- Documented or suspected, clinically significant, alcohol or drug abuse.
- Known allergies or intolerances to alginates.
- Any active malignant disease (with the exception of basal cell carcinoma; BCC).
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol.
- Haemoptysis more than 60 mL at any time within 30 days before study drug administration.
- Participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.
- Males who intend to father a child in 3 months following study or are unwilling to abstain from sexual intercourse with pregnant or lactating women. Females who are intending to become pregnant in 3 months following study.
- Any non-removable metal objects such as metal plates, screws etc in their head, neck, chest or abdominal area.
- As a result of a physical examination or screening investigations, the physician responsible considers the patient unfit for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients
OligoG is a new potential treatment which is being developed by AlgiPharma AS (a Norwegian-based company) with an aim to help people with cystic fibrosis in the future.
OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to reduce mucus thickness and improve mucus clearance. It could also have the benefit of reducing the incidence of infections.
Read more
Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups tolerated the medication well, with no treatment related issues reported. The dose administered in this study is lower; patients who complete the study will receive, in total, 186 mg of OligoG in two divided doses.
A new dry powder formulation of OligoG has been developed so that patients can use an inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is much quicker and more practical for the patient.
In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is a well-established medical imaging technique. A small amount of radioactive material will be added to both the dry powder and nebulised solution. The radiation emitted will then be detected by taking images using a device known as a gamma camera. The procedure is relatively easy and non-invasive.
The purpose of this study is to help answer the following research questions:
- How do the OligoG dry powder and nebulised solution distribute in the lungs of patients with cystic fibrosis?
- How much of the formulation gets to the deep lung?
- How much of the formulation remains in the devices used for administration?
Read the detailed description
The primary efficacy (deposition) variable will be the % dose deposited in the lungs.
The following secondary efficacy (deposition) variables will be determined (where appropriate): Percentage dose deposited in the oropharyngeal, oesophageal and gastric regions Percentage dose remaining in the Miat Monodose inhaler Percentage dose remaining in the nebuliser mouthpiece Percentage dose remaining in the nebuliser reservoir Percentage dose deposited on the exhalation filter (if appropriate) Percentage dose contained in mouth washing(s) Penetration index based on the ratio of counts in the central:peripheral lung regions (C/P index)
- Conditions
- Cystic Fibrosis
- Being tested
- Radiolabelled OligoG CF-5/20 DPI, Radiolabelled OligoG CF-5/20 6% Solution
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabelled OligoG CF-5/20 DPIDrug
Also called Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation
Inhalation with dry powder by Mia Monodose Inhaler
Radiolabelled OligoG CF-5/20 6% SolutionDrug
Also called Radiolabelled OligoG CF-5/20 Solution
Inhalation with aerosolised solution by nebuliser
| Study group | Role | What they receive |
|---|---|---|
| Radiolabelled OligoG CF-5/20 DPI | Experimental | Single dose OligoG CF-5/20 Dry Powder for Inhalation by 3 capsules of 32mg OligoG via Miat Monodose Inhaler, radiolabelled ca10MBq 99mTc. Receives: Drug: Radiolabelled OligoG CF-5/20 DPI |
| Radiolabelled OligoG CF-5/20 6% Solution | Active comparator | Single dose of 1.5mL (90mg) aerosolised OligoG CF-5/20 6% solution via Sidestream Plus nebuliser, radiolabelled ca10MBq 99mTc. Receives: Drug: Radiolabelled OligoG CF-5/20 6% Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To qualitatively determine the deposition of radiolabelled OligoG in the lung.
Measured: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)
Secondary outcomes (2)
To determine the radiolabel distribution pattern of the two formulations in the diseased lung, including calculating the ratio of radiolabel in the central airways compared to the peripheral region (C/P index)
Measured: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)
To characterise the extrapulmonary deposition (i.e. oropharyngeal and stomach) of radiolabel including retention in the nebuliser or dry powder inhaler reservoir and deposition on the exhalation filter (if appropriate)
Measured: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- BDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AlgiPharma AS
- Responsible party
- Principal investigator, Howard Stevens, BDD Pharma Ltd
- Investigators
- Howard NE Stevens, PhD, Principal investigator, BDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991028
- Sponsor's protocol ID
- BC-180-12
- Status last verified
- Feb 2015
- First submitted
- 18 Nov 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT01991028
- Acronym / sponsor ID
- BC-180-12
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BDD Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- AlgiPharma AS
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Nov 2013 (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.
OligoG is a new potential treatment which is being developed by AlgiPharma AS (a Norwegian-based company) with an aim to help people with cystic fibrosis in the future.
OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to reduce mucus thickness and improve mucus clearance. It could also have the benefit of reducing the incidence of infections.
Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups tolerated the medication well, with no treatment related issues reported. The dose administered in this study is lower; patients who complete the study will receive, in total, 186 mg of OligoG in two divided doses.
A new dry powder formulation of OligoG has been developed so that patients can use an inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is much quicker and more practical for the patient.
In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is a well-established medical imaging technique. A small amount of radioactive material will be added to both the dry powder and nebulised solution. The radiation emitted will then be detected by taking images using a device known as a gamma camera. The procedure is relatively easy and non-invasive.
The purpose of this study is to help answer the following research questions:
- How do the OligoG dry powder and nebulised solution distribute in the lungs of patients with cystic fibrosis?
- How much of the formulation gets to the deep lung?
- How much of the formulation remains in the devices used for administration?
Detailed description
The primary efficacy (deposition) variable will be the % dose deposited in the lungs.
The following secondary efficacy (deposition) variables will be determined (where appropriate): Percentage dose deposited in the oropharyngeal, oesophageal and gastric regions Percentage dose remaining in the Miat Monodose inhaler Percentage dose remaining in the nebuliser mouthpiece Percentage dose remaining in the nebuliser reservoir Percentage dose deposited on the exhalation filter (if appropriate) Percentage dose contained in mouth washing(s) Penetration index based on the ratio of counts in the central:peripheral lung regions (C/P index)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiolabelled OligoG CF-5/20 DPI | Experimental | Drug: Radiolabelled OligoG CF-5/20 DPISingle dose OligoG CF-5/20 Dry Powder for Inhalation by 3 capsules of 32mg OligoG via Miat Monodose Inhaler, radiolabelled ca10MBq 99mTc. |
| Radiolabelled OligoG CF-5/20 6% Solution | Active comparator | Drug: Radiolabelled OligoG CF-5/20 6% SolutionSingle dose of 1.5mL (90mg) aerosolised OligoG CF-5/20 6% solution via Sidestream Plus nebuliser, radiolabelled ca10MBq 99mTc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged at least 18 years at screening. Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities.
- i.Clinical features consistent with the diagnosis of cystic fibrosis (Rosenstein et al., 1998); AND ii.Sweat chloride ≥ 60 mmol/L by pilocarpine iontophoresis; OR iii.Genotypic confirmation of 2 CF-causing mutations
- Positive microbiological finding of Pseudomonas aeruginosa (mucoid or nonmucoid) in expectorated sputum (and/or swab) documented within the last 24 months prior to screening. Negative finding is acceptable provided the proportion of patients enrolled with positive findings is at least 80%.
- At screening, FEV1 must be between 35 and 80% of the predicted normal value following adjustment for age, gender and height according to the Knudson equation (Knudson et al., 1983)
Key exclusion criteria (17 listed)
- On-going acute illness. Patients must not have needed an outpatient visit, hospitalisation or required any change in therapy for other pulmonary disease between screening and AV1.
- History of, or planned organ transplantation.
- Requirement for continuous (24 hour/day) oxygen supplementation.
- Concomitant administration of inhaled mannitol or hypertonic saline within 48 hours of Period 1, Day 1.
- Clinically significant abnormal findings on haematology or clinical chemistry. In addition, any value ≥ 3 x the upper limit of normal will exclude the patient from participating in the study.
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 |
|---|---|---|
| Radiolabelled OligoG CF-5/20 DPIAlso: Radiolabelled OligoG CF-5/20 Dry Powder for InhalationInhalation with dry powder by Mia Monodose Inhaler | Drug | Radiolabelled OligoG CF-5/20 DPI |
| Radiolabelled OligoG CF-5/20 6% SolutionAlso: Radiolabelled OligoG CF-5/20 SolutionInhalation with aerosolised solution by nebuliser | Drug | Radiolabelled OligoG CF-5/20 6% Solution |
Primary outcome
To qualitatively determine the deposition of radiolabelled OligoG in the lung.
Time frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)
2 secondary outcomes
To determine the radiolabel distribution pattern of the two formulations in the diseased lung, including calculating the ratio of radiolabel in the central airways compared to the peripheral region (C/P index)
Time frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)
To characterise the extrapulmonary deposition (i.e. oropharyngeal and stomach) of radiolabel including retention in the nebuliser or dry powder inhaler reservoir and deposition on the exhalation filter (if appropriate)
Time frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
Howard NE Stevens, PhD principal investigator
BDD Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiolabelled OligoG CF-5/20 DPI and Radiolabelled OligoG CF-5/20 6% Solution in people with Cystic Fibrosis, run by BDD Pharma Ltd at 1 site in United Kingdom.
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 9 inclusion and 17 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: finished, as of the sponsor's last update on 9 Feb 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To qualitatively determine the deposition of radiolabelled OligoG in the lung. (time frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)). 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 9 Feb 2015.