A randomised, double-blind, placebo-controlled Phase II study, comparing the efficacy and safety of inhaled SNG001 to placebo administered to COPD patients after the onset of a respiratory viral infection for the prevention or attenuation of COPD symptoms caused by respiratory viruses - Phase II: Inhaled SNG001 in COPD subjects

• Conditions: Prevention or attenuation of COPD symptoms caused by respiratory viruses

• Registration Number: EUCTR2010-022110-29-GB
• Lead Sponsor: Synairgen Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1)Male or female, over 40 years of age.
2)A confirmed diagnosis of COPD or a medical history consistent with a diagnosis of COPD.
3)FEV1 > 20% of predicted and < 70% of predicted post-bronchodilator, on the day of screening.
4)To have had at least one COPD exacerbation suspected to have been caused by a respiratory virus in the last 24 months requiring intervention with oral steroids or antibiotics.
5)Has experienced respiratory virus symptoms that have developed within the previous 48 hours, but preferably 24 hours, specifically a blocked or runny nose, and a sore or scratchy throat.
6)Provide written informed consent.
7)Females of child-bearing potential must be using a medically acceptable and adequate form of birth control and agree to maintain this usage throughout the duration of the study.
8)Motivation (in the Investigator’s opinion) to complete all study visits and assessments, the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment, including its risks and benefits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Any condition, including findings in the medical history that, in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation.
2)Patients who have a current moderate or severe exacerbation of COPD.
3)Oxygen saturation of less than 92% (taken on air, unless the subject is routinely prescribed oxygen when they are stable).
4)Current participation in an interventional trial.
5)Patients who have received a dose of a test product (IMP) within 12 weeks prior to entry into the study for small molecules and within 6 months prior to entry into the study for biologicals.
6)Patients who have had a COPD exacerbation and/or upper or lower respiratory tract infection that resolved less than 4 weeks ago.
7)Patients who are currently taking, or have taken oral steroids or antibiotics within the last four weeks.
8)Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis or a history of significant chronic asthma.
9)Patients with serious underlying medical conditions that could impact interpretation of results should be excluded (e.g. infection, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease).
10)History of hypersensitivity to natural or recombinant IFN-ß or to any of the drug preparation excipients.
11)Patients with current severe depression and/or suicidal ideation.
12)History of epilepsy or seizures after the age of 5 years.
13)Recent history of drug or alcohol abuse.
14)Female who is breast-feeding, pregnant or intends to become pregnant.
15)Patients who require more than 12 hours’ oxygen therapy per day.
16)Patients who are currently in a pulmonary rehabilitation programme.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified