Cystic FibrosisPhase 2SMR-2591NCT02453789
A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection
A Phase 2 study testing Alginate oligosaccharide in people with Cystic Fibrosis and Burkholderia Infection, run by AlgiPharma AS at 2 sites in Germany.
Trial summary
The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Burkholderia Infection
- What is being tested?
- Alginate oligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2015to Dec 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
- Ability to provide sputum samples for microbiological evaluation throughout the study either spontaneously or induced.
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- Chronic colonization with Burkholderia spp. defined as at least two positive microbiological cultures in expectorated sputum within the last 12 months from Visit 1.
- Use of inhaled aztreonam three times daily in a 4 weeks on/off cycle treatment regimen or a continuous intake regimen for at least 4 weeks before screening visit. For on/off cycles, screening visit should take place in the off phase. Randomization visit should take place the first day "on" to harmonize the aztreonam inhalation period with the IMP intake period.
- Willingness to stop treatment with other inhaled antibiotics.
- At Screening no clinical or laboratory findings suggestive of significant pulmonary illness, other than CF, which in the opinion of the investigator would preclude participation in the study.
- FEV1 greater than 25% of the predicted normal value following adjustment for age, gender, and height according to the Global Lung Initiative
- Female subjects of child bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Female subjects documented as being of non-child-bearing potential are exempt from the contraceptive requirements.
- Provision of 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 at Day 98.
- Changes in physiotherapy technique or schedule within 14 days prior to Day 0.
- Prohibited medications within 7 days prior to Day 0. Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 0.
- Concomitant use of inhaled antibiotics other than aztreonam.
- Pulmonary exacerbation within 28 days of Screening.
- Lactose intolerance/milk allergy.
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- 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.
- Active allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening, defined as having received treatment for ABPA.
- Inability or unwillingness to provide sputum samples for microbiological evaluation throughout the study either spontaneously or induced by means of using inhaled hypertonic saline.
- 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 at Screening.
- Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 0.
- Subjects with documented or suspected, clinically significant, alcohol or drug abuse, as determined by the Investigator.
- Current 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 subject treatment, assessment, or compliance with the protocol.
- Patients not willing/able to follow the study instructions.
- Resistance to aztreonam, or intolerance to aztreonam or any of its excipients.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Universitätsmedizin Berlin
Berlin, 13353
Pneumologische Praxis Pasing
Münich, Münich-Pasing, 81241
About this study
Official title: A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.
The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.
Read the detailed description
Primary objective:
To explore the efficacy of inhaled OligoG in reducing the microbial burden of Burkholderia spp. as measured in expectorated sputum samples.
Secondary objectives:
To explore the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures.
To evaluate the safety, tolerability and subject compliance with treatment The study will also evaluate the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures, and evaluate the safety and patient compliance with treatment.
- Conditions
- Cystic Fibrosis, Burkholderia Infection
- Being tested
- Alginate oligosaccharide, Placebo
- Keywords
- alginate oligosaccharide, cystic fibrosis, Burkholderia, aztreonam
- Medical subject headings
- Cystic Fibrosis, Burkholderia Infections
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 of dry powder for inhalation (DPI)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Alginate oligosaccharide | Active comparator | Inhalation of a dry powder OligoG in the first treatment period, and placebo in 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: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum.
Measured: 28 days, i.e. at start and end of treatment
Secondary outcomes (4)
Clinical safety as measured by vital signs
Measurement of vital signs
Measured: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112
Clinical safety as measured by ECG
Measurement of ECG
Measured: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112
Clinical safety as measured by blood oxygen saturation
Measurement of blood oxygen saturation
Measured: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112
Clinical safety as measured by FEV1 (Forced Expiratory Volume in 1 second)
Measurement of pulmonary function tests
Measured: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlgiPharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainald Fischer, MD, PD, Principal investigator, Pneumologische Praxis Pasing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453789
- Sponsor's protocol ID
- SMR-2591
- Acronym
- SMR-2591
- Status last verified
- Apr 2018
- First submitted
- 14 May 2015
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischer R, Schwarz C, Weiser R, Mahenthiralingam E, Smerud K, Meland N, Flaten H, Rye PD. Evaluating the alginate oligosaccharide (OligoG) as a therapy for Burkholderia cepacia complex cystic fibrosis lung infection. J Cyst Fibros. 2022 Sep;21(5):821-829. doi: 10.1016/j.jcf.2022.01.003. Epub 2022 Jan 24.
PubMed 35086790Hurley 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 Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.
- ClinicalTrials.gov ID
- NCT02453789
- Acronym / sponsor ID
- SMR-2591 / SMR-2591
- Conditions
- Cystic Fibrosis, Burkholderia Infection
- Keywords
- alginate oligosaccharide, cystic fibrosis, Burkholderia, aztreonam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AlgiPharma ASIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 May 2015 (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 to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.
Detailed description
Primary objective:
To explore the efficacy of inhaled OligoG in reducing the microbial burden of Burkholderia spp. as measured in expectorated sputum samples.
Secondary objectives:
To explore the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures.
To evaluate the safety, tolerability and subject compliance with treatment The study will also evaluate the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures, and evaluate the safety and patient compliance with treatment.
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 placebo in the second period |
| Placebo | Placebo comparator | Drug: PlaceboInhalation 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 (13 listed)
- Male or female with a confirmed diagnosis of cystic fibrosis defined by:
- Aged 18 years or older
- Ability to provide sputum samples for microbiological evaluation throughout the study either spontaneously or induced.
- Chronic colonization with Burkholderia spp. defined as at least two positive microbiological cultures in expectorated sputum within the last 12 months from Visit 1.
- Use of inhaled aztreonam three times daily in a 4 weeks on/off cycle treatment regimen or a continuous intake regimen for at least 4 weeks before screening visit. For on/off cycles, screening visit should take place in the off phase. Randomization visit should take place the first day "on" to harmonize the aztreonam inhalation period with the IMP intake period.
Key exclusion criteria (19 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 at Day 98.
- Changes in physiotherapy technique or schedule within 14 days prior to Day 0.
- Prohibited medications within 7 days prior to Day 0. Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 0.
- Concomitant use of inhaled antibiotics other than aztreonam.
- Pulmonary exacerbation within 28 days of 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 of dry powder for inhalation (DPI) | Drug | Alginate oligosaccharide |
| Placebo | Drug | Placebo |
Primary outcome
Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum.
Time frame: 28 days, i.e. at start and end of treatment
4 secondary outcomes
Clinical safety as measured by vital signs
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112
Clinical safety as measured by ECG
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112
Clinical safety as measured by blood oxygen saturation
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112
Clinical safety as measured by FEV1 (Forced Expiratory Volume in 1 second)
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112
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 35086790Fischer R, Schwarz C, Weiser R, Mahenthiralingam E, Smerud K, Meland N, Flaten H, Rye PD. Evaluating the alginate oligosaccharide (OligoG) as a therapy for Burkholderia cepacia complex cystic fibrosis lung infection. J Cyst Fibros. 2022 Sep;21(5):821-829. doi: 10.1016/j.jcf.2022.01.003. Epub 2022 Jan 24.
- 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.
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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.
Rainald Fischer, MD, PD principal investigator
Pneumologische Praxis Pasing
2 sites in 1 country: 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 and Burkholderia Infection, run by AlgiPharma AS at 2 sites 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 13 inclusion and 19 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 2 sites 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 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?
Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. (time frame: 28 days, i.e. at start and end of treatment). 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 NCT02453789, which also lists 2 linked publications.
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.