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Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Smerud Medical Research International AS
Information provided by:
AlgiPharma AS
ClinicalTrials.gov Identifier:
NCT00970346
First received: September 1, 2009
Last updated: June 25, 2010
Last verified: June 2010
History of Changes
  Purpose

Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic duct, and in the reproductive system. OligoG CF-5/20 has been shown to reduce sputum from CF patients. The objective of this study is to determine the safety and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy volunteers.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AlgiPharma AS:

Primary Outcome Measures:
  • To determine the safety and local tolerability of multiple dose administration of inhaled alginate oligosaccharide (OligoG CF-5/20) fragment in healthy volunteers, particular emphasis will be put on pulmonary functioning and pulmonary adverse events. [ Time Frame: 3 days dosing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled OligoG CF-5/20 Drug: OligoG CF-5/20
Inhaled OligoG CF-5/20 will be given to healthy volunteers with different concentrations to test tolerability of the drug

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, male subjects aged 18 to 65 years inclusive
  • Normal pulmonary function; i.e. FEV1 ≥ 80% of predicted (for age, sex, height and race) and FEV1/FVC ratio ≥ 0.7
  • Subject's pre -study physical examination, vital signs and electrocardiogram (ECG) are normal or do not show any clinically significant abnormalities as determined by the investigator
  • Subject's pre - study laboratory screen are normal or, if outside of the laboratory reference range, not considered clinically significant

Exclusion Criteria:

  • History of any clinically relevant chronic respiratory disorder, including asthma
  • Current smoker or smoked within the last 12 months
  • History of significant drug or alcohol abuse (defined by the investigator). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
  • Subject who has inhaled any drug in the last 30 days prior to Day 1
  • Subject who has received one or more days of systemic pharmacological treatment in the 14 days immediately prior to Day 1
  • Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks
  • Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or metabolic disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970346

Locations
United Kingdom
Merthyr Tydfil, United Kingdom
Sponsors and Collaborators
AlgiPharma AS
Smerud Medical Research International AS
Investigators
Principal Investigator: Salvatore Febbraro Simbec Research
  More Information

No publications provided

Responsible Party: Rolf Myrvold, AlgiPharma
ClinicalTrials.gov Identifier: NCT00970346     History of Changes
Other Study ID Numbers: SMR-1916
Study First Received: September 1, 2009
Last Updated: June 25, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AlgiPharma AS:
Digestive System Diseases
Genetic Diseases
Inborn
Respiratory Tract Diseases
 Cystic Fibrosis
Lung Disease
Pancreatic Diseases

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 June 17, 2013