Cystic FibrosisPhase 2SMR-2984NCT02157922
A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis
A Phase 2 study testing alginate oligosaccharide in people with Cystic Fibrosis, run by AlgiPharma AS at 18 sites in 5 countries.
Trial summary
The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis. 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?
- alginate oligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Oct 2014to Sep 2017
- 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
- Male or female with a confirmed diagnosis of cystic fibrosis defined by:
- Clinical features consistent with the diagnosis of CF AND Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR
- Genotypic confirmation of CFTR mutation
- Aged 18 years or older
- Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab within 24 months prior to Screening
- FEV1 between 40%-100%
Show all 9Show fewer
- At Screening no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF
- Female subjects of child bearing potential and sexually active male subjects must use contraception
- Provision written informed consent
Who cannot join
- Changes in underlying therapy within the 14 days prior to Day 0. Subjects must be willing to remain on the same underlying stable therapy regimens for the duration of the study until the final follow-up visit.
- Changes in physiotherapy technique or schedule within 14 days prior to Day 0.
- Prohibited medications within 7 days prior to Day 0.
- Pulmonary exacerbation within 28 days of Screening.
- Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening.
- Lactose intolerance/milk allergy.
Show all 26Show fewer
- On-going acute illness. Subjects must not have needed an outpatient visit, hospitalization or required any change in therapy for other pulmonary disease between Screening and Day 0.
- History of, or planned organ transplantation.
- Treatment for Allergic bronchopulmonary aspergillosis (ABPA).
- Requirement for continuous (24 hour/day) oxygen supplementation.
- Diagnosed with the G551D-mutation, and currently on concomitant treatment with Ivacaftor (Kalydeco).
- Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 0 (Visit 2).
- Initiation of cycled, inhaled tobramycin (TOBI) and Colistin less than 4 months prior to Screening (Visit 1). Note: Chronic TOBI and Colistin users are allowed to participate in this study, but subjects who have recently initiated chronic TOBI or Colistin should have at least 2 cycles of TOBI or Colistin respectively in the preceding 4 months before being enrolled in this study. Treatment should be phased in line with the antibiotic treatment.
- Concomitant use of all other marketed antibiotic agents is permitted, providing subjects are willing to remain on the same regimens within the 28 days immediately prior to Day 0 and for the entire duration of the study (until the follow-up visit).
- Clinically significant abnormal findings on haematology or clinical chemistry. In addition, any value ≥ 3 x the upper limit of normal will exclude the subject from participating in the study.
- Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.
- Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in females of child-bearing potential (Section 4.2.9) at Screening.
- Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 0 (Visit 2).
- Subjects with documented or suspected, clinically significant, alcohol or drug abuse.
- Current malignant disease (with the exception of basal cell carcinoma and cervical neoplasia).
- Any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
- DPI intolerance, active or placebo
- For MCC sites only:
- Smoking. A negative Cotinine test must be demonstrated at Screening
- Subjects who have any non-removable metal objects such as metal plates, screws etc in their head, neck, chest or abdominal area
- Subjects for whom 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.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Germany7 sites
Pediatric Pulmonology and Immunology, Charité Universitätsmedizin
Berlin, 13353
CF Zentrum Köln, Universitätskrankenhaus Köln
Cologne, 50924
Medizinische Klinik I, Pneumologie, Uniklinik
Frankfurt, 60590
Klinik für Pneumologie, CF-Ambulanz
Hanover, 30625
Mukoviszidose-Zentrum für Erwachsene, Med. Klinik V-Innenstadt (LMU)
Münich, 80336
Pneumologische Praxis Pasing
Münich, 81241
Center for Pediatric Clinical Studies,
Tübingen, 72076
United Kingdom7 sites
Regional Respiratory Centre, Belfast City Hospital
Belfast, BT9 7AB
Papworth Hospital
Cambridge, CB23 3RE
Bio-Images Research Ltd, Basement Medical Block, Within GRI
Glasgow, G4 0SF
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
Queens Medical Centre
Nottingham, NG7 2UH
Southampton General Hospital
Southampton
Sweden2 sites
CF-mottagningen, Sahlgrenska Universitetssjukhuset
Gothenburg, 41345
Stockholm CF-center, Karolinska Universitetssjukhuset
Stockholm, 14186
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis
The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.
Read the detailed description
The primary objective is to demonstrate efficacy of inhaled OligoG measured by FEV1, and supported by secondary endpoints including Mucociliary Clearance, rheology,microbiology and Quality-of-Life.
The secondary objectives are
- To demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation after multiple dose administration; and
- To evaluate patient compliance with treatment.
The design will be randomized, double-blind, placebo-controlled, multi-center, cross-over phase II study. Mucociliary and Cough clearance (MCC) will be an exploratory endpoint in a subset of 24 patients, and Lung Clearance Index (LCI) an exploratory endpoint in another subset of 20 or more patients.
- Conditions
- Cystic Fibrosis
- Being tested
- alginate oligosaccharide
- Keywords
- Cystic fibrosis, mucolytic, mucociliary clearance, lung clearance
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alginate oligosaccharideDrug
Also called OligoG
Inhalation
| Study group | Role | What they receive |
|---|---|---|
| Alginate oligosaccharide | Active comparator | Inhalation of a dry powder OligoG in the first treatment period, and of placebo the second period Receives: Drug: alginate oligosaccharide |
| Placebo | Placebo comparator | Inhalation of placebo dry powder in the first treatment period, and OligoG in the second period Receives: Drug: alginate oligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 (Forced Expiratory Volume in 1 second)
An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.
Measured: 28 days, i.e. start and end of treatment periods
Secondary outcomes (1)
Mucociliary and cough clearance
Mucociliary clearance is assessed by measuring the movement of an inhaled radiotracer up the airways.
Measured: 28 days, i.e. start and end of treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlgiPharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurostars, Smerud Medical Research International AS
- Responsible party
- Sponsor
- Investigators
- Tacjana Pressler, PhD MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157922
- Sponsor's protocol ID
- SMR-2984
- Acronym
- SMR-2984
- Status last verified
- Aug 2016
- First submitted
- 4 Jun 2014
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hurley MN, Smith S, Forrester DL, Smyth AR. Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis. Cochrane Database Syst Rev. 2020 Jul 16;7(7):CD008037. doi: 10.1002/14651858.CD008037.pub4.
PubMed 32671834
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02157922
- Acronym / sponsor ID
- SMR-2984 / SMR-2984
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, mucolytic, mucociliary clearance, lung clearance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AlgiPharma ASIndustry (pharma, biotech, devices)
- Collaborators
- Eurostars, Smerud Medical Research International AS
- Study start
- Oct 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Jun 2014 (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 the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.
Detailed description
The primary objective is to demonstrate efficacy of inhaled OligoG measured by FEV1, and supported by secondary endpoints including Mucociliary Clearance, rheology,microbiology and Quality-of-Life.
The secondary objectives are
- To demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation after multiple dose administration; and
- To evaluate patient compliance with treatment.
The design will be randomized, double-blind, placebo-controlled, multi-center, cross-over phase II study. Mucociliary and Cough clearance (MCC) will be an exploratory endpoint in a subset of 24 patients, and Lung Clearance Index (LCI) an exploratory endpoint in another subset of 20 or more patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alginate oligosaccharide | Active comparator | Drug: alginate oligosaccharideInhalation of a dry powder OligoG in the first treatment period, and of placebo the second period |
| Placebo | Placebo comparator | Drug: alginate oligosaccharideInhalation of placebo dry powder in the first treatment period, and OligoG in the second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female with a confirmed diagnosis of cystic fibrosis defined by:
- Aged 18 years or older
- Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab within 24 months prior to Screening
- FEV1 between 40%-100%
- At Screening no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF
Key exclusion criteria (26 listed)
- Changes in underlying therapy within the 14 days prior to Day 0. Subjects must be willing to remain on the same underlying stable therapy regimens for the duration of the study until the final follow-up visit.
- Changes in physiotherapy technique or schedule within 14 days prior to Day 0.
- Prohibited medications within 7 days prior to Day 0.
- Pulmonary exacerbation within 28 days of Screening.
- Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening.
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 |
|---|---|---|
| alginate oligosaccharideAlso: OligoGInhalation | Drug | Alginate oligosaccharide, Placebo |
Primary outcome
FEV1 (Forced Expiratory Volume in 1 second)
Time frame: 28 days, i.e. start and end of treatment periods
An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.
1 secondary outcome
Mucociliary and cough clearance
Time frame: 28 days, i.e. start and end of treatment periods
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 19 Apr 2018.
- Derived from this study: PubMed 32671834Hurley MN, Smith S, Forrester DL, Smyth AR. Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis. Cochrane Database Syst Rev. 2020 Jul 16;7(7):CD008037. doi: 10.1002/14651858.CD008037.pub4.
- Individual participant dataSharing planned: Undecided
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Tacjana Pressler, PhD MD principal investigator
Copenhagen University Hospital, Rigshospitalet
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alginate oligosaccharide in people with Cystic Fibrosis, run by AlgiPharma AS at 18 sites in 5 countries.
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 26 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, United Kingdom, Sweden, Denmark, Norway. 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 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?
FEV1 (Forced Expiratory Volume in 1 second) (time frame: 28 days, i.e. start and end of treatment periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157922, which also lists 1 linked publication.
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 19 Apr 2018.