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
  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:


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
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: 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 August 28, 2014