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

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. Identifier: NCT00970346
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : March 23, 2016
Smerud Medical Research International AS
Information provided by (Responsible Party):
AlgiPharma AS

Brief Summary:
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. 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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: OligoG CF-5/20 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00970346

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

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Responsible Party: AlgiPharma AS Identifier: NCT00970346    
Other Study ID Numbers: SMR-1916
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Keywords provided by AlgiPharma AS:
Digestive System Diseases
Genetic Diseases
Respiratory Tract Diseases
Cystic Fibrosis
Lung Disease
Pancreatic Diseases
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases