Cystic FibrosisPhase 2/3SMR3372NCT03698448
A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis
A Phase 2/3 study testing OligoG Dry powder for inhalation in people with Cystic Fibrosis, run by AlgiPharma AS at 1 site in Germany.
Trial summary
Randomized, double blind, placebo controlled study. The study has two parts: Dose-finding part, followed by longer term follow-up (6 months) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- OligoG Dry powder for inhalation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2021to 1 Nov 2022
- Phase
- Phase 2/3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CF
- FEV1 at screening >40 and < 90% of predicted normal
- History of PA infection in last 12 m
- History of antibiotic treatment due tp PA infection (not for eradication) during last 12 m
- Concomitant inhaled tobramycin, colistin, aztreonam, or levoflaxin (cycled or continuous)
- Stable CF disease
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- Willing to remain on stable CF medication (Standard of care)
- Women of child-bearing potential must habe negative urine pregnany test
- Males \& females must use acceptable contraception
- Capable of inhaling dry powder
- willing to sign informed consent
- willing and able to follow study procedures
Who cannot join
- Use of hypertonic saline > twice daily
- Clinically significant abnormal lab findings, except CRP. In case of high GGT values, case will be discussed by experts before deciding
- History of comorbidity that may distort results or cause additional risk
- pulmonary exacerbation within 28 days prior to randomisation
- Change in CF therapy within 28 days prior to randomisation
- Burkholderia spp. finding within 12 m prior to screening
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- pregnant or breast feeding females
- History of allergic reactions to IMP ingredients, incl milk protein
- Inability to perform lung function tests according to ATS/ ERS criteria
- Uncontrolled or unstable diseases that might limit compliance
- History of, or planned organ transplantation
- Allergic ABPA in the last 12 months prior to the screening visit
- Requirement for continuous oxygen supplementation
- Current participation in another clinical study
- medical condition, other than CFwhich exposes the patient to an unacceptably high risk
- Concurrent mlignant disease, except BCC and cervical neoplasia
- Clinically significant alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis
Randomized, double blind, placebo controlled study. The study has two parts:
Dose-finding part, followed by longer term follow-up (6 months)
Read the detailed description
Part 1: Randomized, double blind, placebo controlled dose-finding. Patients will be assigned to 1 of 3 doses OligoG, or to placebo, on top of Standard of Care. Patients will be treated for 12 weeks, followed by 4 weeks washout.The primary endpoint is relative change in % predicted FEV1. Secondary endpoints include additional spirometry parameters, exacerbation rate, Quality of Life, sputum rheology and microbiology, safety laboratory tests and adverse event reporting.
Part 2: Randomized double-blind 6 -month study, for longer term follow-up of the dose identified in Part 1. New patients will be recruited in part 2, in addition to patients who received placebo in Part 1. In addition to the endpoints studied in Part 1, Part 2 will include Lung Clearance Index (LCI), chest imaging by MRI or CT, and pharmaco-economic parameters.
- Conditions
- Cystic Fibrosis
- Being tested
- OligoG Dry powder for inhalation
- Keywords
- Oligosaccharide
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OligoG Dry powder for inhalationDrug
Also called Placebo dry powder for inhalation
10 capsules Dry Powder for Inhalation, BID
| Study group | Role | What they receive |
|---|---|---|
| Placebo DPI | Placebo comparator | Matching placebo dry powder for inhalation. OligoG is replaced by lactose. 10 capsules, BID Receives: Drug: OligoG Dry powder for inhalation |
| Low dose OligoG DPI | Active comparator | 17.5 mg OligoG dry powder for inhalation. 10 capsules, BID Receives: Drug: OligoG Dry powder for inhalation |
| medium dose OligoG DPI | Active comparator | 27.5 mg OligoG dry powder for inhalation. 10 capsules, BID Receives: Drug: OligoG Dry powder for inhalation |
| High dose OligoG DPI | Active comparator | 37.5 mg OligoG dry powder for inhalation. 10 capsules, BID Receives: Drug: OligoG Dry powder for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
the amount of air a person can forcefully exhale in one second
Measured: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Secondary outcomes (3)
Lung Clearance Index (LCI) (Part two only)
Lung clearance index (LCI) measured by multiple breath washout is a sensitive measure of ventilation inhomogeneity.
Measured: Change from before to after 26 weeks treatment
Sputum culture microbiology
Reduction in Pseudomonas Aeruginosa CFU Counts and total counts
Measured: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Pulmonary Exacerbations
Acute pulmonary exacerbations
Measured: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Sep 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Why it stopped: Determined not feasible
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double blind, dose-finding
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlgiPharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imperial College London, Cystic Fibrosis Foundation, European Cystic Fibrosis Society, University Hospital of Cologne, Cystic Fibrosis Europe
- Responsible party
- Sponsor
- Investigators
- Silke van Koningsbruggen-Rietschel, MD, PhD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698448
- Sponsor's protocol ID
- 3372
- Other IDs
- 2018-000378-30, 2018
- Acronym
- SMR3372
- Status last verified
- Jun 2022
- First submitted
- 3 Oct 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03698448
- Acronym / sponsor ID
- SMR3372 / 3372
- Conditions
- Cystic Fibrosis
- Keywords
- Oligosaccharide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Determined not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AlgiPharma ASIndustry (pharma, biotech, devices)
- Collaborators
- Imperial College London, Cystic Fibrosis Foundation, European Cystic Fibrosis Society, University Hospital of Cologne, Cystic Fibrosis Europe
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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.
Randomized, double blind, placebo controlled study. The study has two parts:
Dose-finding part, followed by longer term follow-up (6 months)
Detailed description
Part 1: Randomized, double blind, placebo controlled dose-finding. Patients will be assigned to 1 of 3 doses OligoG, or to placebo, on top of Standard of Care. Patients will be treated for 12 weeks, followed by 4 weeks washout.The primary endpoint is relative change in % predicted FEV1. Secondary endpoints include additional spirometry parameters, exacerbation rate, Quality of Life, sputum rheology and microbiology, safety laboratory tests and adverse event reporting.
Part 2: Randomized double-blind 6 -month study, for longer term follow-up of the dose identified in Part 1. New patients will be recruited in part 2, in addition to patients who received placebo in Part 1. In addition to the endpoints studied in Part 1, Part 2 will include Lung Clearance Index (LCI), chest imaging by MRI or CT, and pharmaco-economic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised, double blind, dose-finding
| Arm | Type | Receives |
|---|---|---|
| Placebo DPI | Placebo comparator | Drug: OligoG Dry powder for inhalationMatching placebo dry powder for inhalation. OligoG is replaced by lactose. 10 capsules, BID |
| Low dose OligoG DPI | Active comparator | Drug: OligoG Dry powder for inhalation17.5 mg OligoG dry powder for inhalation. 10 capsules, BID |
| medium dose OligoG DPI | Active comparator | Drug: OligoG Dry powder for inhalation27.5 mg OligoG dry powder for inhalation. 10 capsules, BID |
| High dose OligoG DPI | Active comparator | Drug: OligoG Dry powder for inhalation37.5 mg OligoG dry powder for inhalation. 10 capsules, BID |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of CF
- FEV1 at screening >40 and < 90% of predicted normal
- History of PA infection in last 12 m
- History of antibiotic treatment due tp PA infection (not for eradication) during last 12 m
- Concomitant inhaled tobramycin, colistin, aztreonam, or levoflaxin (cycled or continuous)
Key exclusion criteria (17 listed)
- Use of hypertonic saline > twice daily
- Clinically significant abnormal lab findings, except CRP. In case of high GGT values, case will be discussed by experts before deciding
- History of comorbidity that may distort results or cause additional risk
- pulmonary exacerbation within 28 days prior to randomisation
- Change in CF therapy within 28 days prior to randomisation
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 |
|---|---|---|
| OligoG Dry powder for inhalationAlso: Placebo dry powder for inhalation10 capsules Dry Powder for Inhalation, BID | Drug | High dose OligoG DPI, Low dose OligoG DPI, Placebo DPI, medium dose OligoG DPI |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
the amount of air a person can forcefully exhale in one second
3 secondary outcomes
Lung Clearance Index (LCI) (Part two only)
Time frame: Change from before to after 26 weeks treatment
Sputum culture microbiology
Time frame: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Pulmonary Exacerbations
Time frame: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Silke van Koningsbruggen-Rietschel, MD, PhD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OligoG Dry powder for inhalation in people with Cystic Fibrosis, run by AlgiPharma AS 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 12 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: withdrawn, as of the sponsor's last update on 30 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: Change from before to after 12 weeks treatment (Part 1) and 26 weeks (Part 2)). 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 Jun 2022.