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Trial record 1 of 3 for:    Burkholderia Spp.
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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 : Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Burkholderia Infection Drug: Alginate oligosaccharide Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : February 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Alginate oligosaccharide
Inhalation of a dry powder OligoG in the first treatment period, and placebo in the second period
Drug: Alginate oligosaccharide
Inhalation of dry powder for inhalation (DPI)
Other Name: OligoG
Placebo Comparator: Placebo
Inhalation of placebo dry powder in the first treatment period, and OligoG in the second period
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. [ Time Frame: 28 days, i.e. at start and end of treatment ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453789


Locations
Germany
Pneumologische Praxis Pasing
Münich, Münich-Pasing, Germany, 81241
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
AlgiPharma AS
Investigators
Principal Investigator: Rainald Fischer, MD, PD Pneumologische Praxis Pasing
More Information

Responsible Party: AlgiPharma AS
ClinicalTrials.gov Identifier: NCT02453789     History of Changes
Other Study ID Numbers: SMR-2591
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: August 2016

Keywords provided by AlgiPharma AS:
alginate oligosaccharide
cystic fibrosis
Burkholderia
aztreonam

Additional relevant MeSH terms:
Burkholderia Infections
Infection
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Alginic acid
Aztreonam
Hemostatics
Coagulants
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents