A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AlgiPharma AS
ClinicalTrials.gov Identifier:
NCT01465529
First received: October 31, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine the safety and local tolerability of multiple dose administration of inhaled OligoG in CF subjects. Particular emphasis will be put on local, clinical tolerance, pulmonary function and pulmonary adverse events. The secondary purpose is to monitor the effect of multiple dose administration of inhaled OligoG on various efficacy variables, such as mucolytic activity, lung function, respiratory symptoms, Quality-of-Life and microbiological outcome measures.


Condition Intervention Phase
Cystic Fibrosis
Drug: OligoG CF-5/20
Drug: Saline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa

Resource links provided by NLM:


Further study details as provided by AlgiPharma AS:

Primary Outcome Measures:
  • Safety and local tolerability of multiple dose administration of inhaled OligoG in Cystic Fibrosis subjects. [ Time Frame: Day 111 + 6 month follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The effect of multiple dose administration of inhaled OligoG on various efficacy variables [ Time Frame: Day 111 + 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: May 2011
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: OligoG CF-5/20
6% OligoG CF-5/20 in water
Other Name: OligoG
Placebo Comparator: Placebo Drug: Saline
0.9% NaCl in water

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 [(Rosenstein BJ and Cutting GR 1998)]; AND
    • Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR
    • Genotypic confirmation of CFTR mutation
  • Aged 18 years or older
  • Ability to provide samples for microbiological evaluation throughout the study. Note: sputum samples are preferred however cough swabs may be performed on occasions where sputum cannot be collected.
  • Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or cough swab documented within 24 months prior to Screening (Visit 1).
  • FEV1 must, at Screening (Visit 1), be between 35%-80% of the predicted normal value following adjustment for age, gender, and height according to the Knudson equation [(Knudson RJ., Lebowitz MD., et al 1983)].
  • At Screening (Visit 1), 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.
  • 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 (Section 4.2.8) are exempt from the contraceptive requirements. For the purpose of this study acceptable contraception is defined as:

    • oral, injected or implanted hormonal methods of contraception;OR
    • placement of an intrauterine device (IUD) or intrauterine system (IUS);OR
    • barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  • Provision written informed consent

Exclusion Criteria:

  • Changes in underlying therapy (e.g., pulmonary massage therapy, bronchodilators, NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and DNase within the 21 days prior to Day 1 (Visit 2). 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 111.
  • Changes in physiotherapy technique or schedule within 14 days prior to Day 1 (Visit 2).
  • Prohibited medications within 7 days prior to Day 1 (Visit 2). Prohibited medications are described in Section 5.6
  • Pulmonary exacerbation within 28 days of Screening (Visit 1).
  • Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough swab documented within 12 months prior to Screening (Visit 1).
  • 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 (Visit 1) and Day 1 (Visit 2).
  • History of, or planned organ transplantation.
  • Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to Screening (Visit 1), defined as having received treatment for ABPA.
  • Requirement for continuous (24 hour/day) oxygen supplementation.
  • Concomitant administration of inhaled mannitol or hypertonic saline within 7 days prior to Day 1 (Visit 2).
  • Initiation of cycled, inhaled tobramycin (TOBI) less than 4 months prior to Screening (Visit 1). Note: Chronic TOBI users are allowed to participate in this study, but subjects who have recently initiated chronic TOBI should have at least 2 cycles of TOBI in the preceding 4 months before being enrolled in this study. Chronic TOBI subjects should be starting an 'off- TOBI' period at Day 1 (Visit 2) so there will be no concomitant dosing of TOBI and assigned study medication.
  • 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 4.2.8) at Screening (Visit 1).
  • Subjects who have participated in any interventional clinical trial within the 28 days prior to Day 1 (Visit 2).
  • Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the Investigator.
  • Known allergies or intolerance to alginates (e.g., foods and food additives based on seaweed extracts).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465529

Locations
Ireland
Beaumont Hospital
Dublin, Ireland, Dublin 9
University College Hospital Galway
Galway, Ireland
United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom, L14 3PE
Sponsors and Collaborators
AlgiPharma AS
Investigators
Principal Investigator: Martin Walshaw, MD Liverpool Heart & Chest Hospital, UK
  More Information

No publications provided

Responsible Party: AlgiPharma AS
ClinicalTrials.gov Identifier: NCT01465529     History of Changes
Other Study ID Numbers: SMR-2375, 2010-023090-19
Study First Received: October 31, 2011
Last Updated: April 28, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014