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A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection (SMR-2591)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02453789
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
AlgiPharma AS

Tracking Information
First Submitted Date  ICMJE May 14, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date April 19, 2018
Study Start Date  ICMJE February 2015
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. [ Time Frame: 28 days, i.e. at start and end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • 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 ]
    Measurement of vital signs
  • Clinical safety as measured by ECG [ Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112 ]
    Measurement of ECG
  • 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 ]
    Measurement of blood oxygen saturation
  • 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 ]
    Measurement of pulmonary function tests
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection
Official Title  ICMJE 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.
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Burkholderia Infection
Intervention  ICMJE
  • Drug: Alginate oligosaccharide
    Inhalation of dry powder for inhalation (DPI)
    Other Name: OligoG
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Alginate oligosaccharide
    Inhalation of a dry powder OligoG in the first treatment period, and placebo in the second period
    Intervention: Drug: Alginate oligosaccharide
  • Placebo Comparator: Placebo
    Inhalation of placebo dry powder in the first treatment period, and OligoG in the second period
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
12
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02453789
Other Study ID Numbers  ICMJE SMR-2591
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AlgiPharma AS
Study Sponsor  ICMJE AlgiPharma AS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainald Fischer, MD, PD Pneumologische Praxis Pasing
PRS Account AlgiPharma AS
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP