A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza

NCT03570359 | Completed Phase 2 DMC

• 2 other identifiers: SG0152017-003679-75
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 16

Brief Summary

The aim of the study is to assess the safety of inhaled SNG001 and the ability of inhaled SNG001 to 'switch on' the cells' anti-viral defences in patients with chronic obstructive pulmonary disease (COPD). The study consist of two parts. Part 1 will assess the safety of inhaled SNG001 in ten patients with stable COPD. Part 2 will assess efficacy and safety of inhaled SNG001 in 120 patients with COPD with a cold or COPD exacerbation.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (4)

• Forced Expiratory Volume in 1 second (FEV1)

  Part 1

  from Baseline (pre-treatment on day 1) to day 3

• Peak Expiratory Flow Rate (PEFR)

  Part 1

  from Baseline (pre-treatment on day 1) to day 3

• Anti-viral IFN-stimulated genes in cells from expectorated sputum.

  Part 2

  from Baseline (pre-treatment on day 1) to day 13

• CXCL10 in blood samples.

  Part 2

  from Baseline (pre-treatment on day 1) to day 13

Secondary Outcomes (28)

• Part 1-Safety, adverse events

  from Baseline (pre-treatment on day 1) to day 7-10

• Part 1-Safety, laboratory values

  from Baseline (pre-treatment on day 1) to day 7-10

• Part 1-Safety, vital signs

  from Baseline (pre-treatment on day 1) to day 7-10

• Part 1-Safety, lung function

  from Baseline (pre-treatment on day 1) to day 7-10

• Part 1-Safety, concomitant medication

  from Baseline (pre-treatment on day 1) to day 7-10

Study Arms (2)

Interferon beta 1a

ACTIVE COMPARATOR

Part 1- Interferon beta 1a once a day for 3 days via inhalation Part 2 - Interferon beta 1a once a day for 14 days via inhalation

Drug: Interferon Beta-1A

Placebo

PLACEBO COMPARATOR

Part 1- placebo once a day for 3 days via inhalation Part 2 - placebo once a day for 14 days via inhalation

Other: Placebo

Interventions

Interferon Beta-1A DRUG

Interferon Beta-1A via inhalation

Also known as: SNG001

Interferon beta 1a

Placebo OTHER

Placebo via inhalation

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between and including 40-75 years of age, at the time of the screening visit.
• A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the screening visit.
• Post-bronchodilator FEV1 ≥40% of predicted and FEV1/FVC ratio \<0.7 (at screening).
• FEV1 ≥30% of predicted (at Visit 2, pre-dose).
• Should have stable COPD, having no symptoms of an exacerbation and/or respiratory tract infection currently and/or within the past 6 weeks of screening and/or randomisation.
• Should be prescribed and taking regularly one or more long acting bronchodilators (e.g. long acting β2 agonist \[LABA\], long acting muscarinic antagonist \[LAMA\]) with or without an inhaled corticosteroid maintenance therapy for their COPD.
• Patients who produce sputum most days.
• Provide written informed consent.
• The patient produced an adequate sputum sample at the screening visit.
• Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose. In addition to the acceptable birth control method (except for the practice of total sexual abstinence), condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose to prevent pregnancy.
• Women of childbearing potential must have a negative pregnancy test at screening and prior to randomisation.
• Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:
• Women \<50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range. If the FSH result is not available at the time of randomization, the patient must have a negative pregnancy test and agree to use highly effective contraception methods until the FSH result is available.
• Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
• Motivation (in the Investigator's opinion) to comply with protocol requirements and complete all study visits, including 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 potential benefits).

You may not qualify if:

• Any condition, including findings in the medical history or in the pre-randomisation assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
• Current treatment or treatment within the past 6 weeks with oral corticosteroids.
• Oxygen saturation of ≤ 92%.
• Patients who require any form of oxygen therapy or non-invasive ventilation.
• The patient has received live/attenuated vaccines in the past six weeks prior to randomisation or inactivated/killed, subunit or conjugate vaccines in the past two weeks prior to randomisation.
• Current or previous participation in another clinical trial where the patient has received a dose of an investigational medicinal product (IMP) containing small molecules within 12 weeks prior to entry into this study or containing biologicals within 12 months prior to entry into this study.
• Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha-1 antitrypsin deficiency or a history of significant chronic asthma.
• Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact the interpretation of results (e.g. non respiratory infections, haematological disease, malignancy, renal disease, hepatic disease, coronary heart disease or other cardiovascular disease \[including arrhythmias\], endocrine or gastrointestinal disease).
• History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
• Significant history of depressive disorder or suicidal ideation. Specifically, individuals with current severe depression (i.e. a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required hospitalisation or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past.
• Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy.
• History of drug or alcohol abuse within 12 months prior to enrolment.
• Female who is breast-feeding, pregnant or intends to become pregnant.
• Patients with clinically significant arrhythmias or implantation of permanent pacemaker or implanted cardiac defibrillator.
• Patients with unstable ischaemic heart disease (including, but not limited to, unstable angina or myocardial infarction) or stroke within the preceding 6 months.

Sponsors & Collaborators

• Synairgen Research Ltd.: lead

Study Sites (16)

Celerion

Belfast, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Tower Family Health Care

Bury, United Kingdom

Location

Lakeside Healthcare

Corby, United Kingdom

Location

Gartnavel General Hospital

Glasgow, United Kingdom

Location

Hemel Hempstead Hospital

Hemel Hempstead, United Kingdom

Location

Hull Royal Infirmary

Hull, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Queen Anne Medical Centre

London, United Kingdom

Location

Royal Brompton

London, United Kingdom

Location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

North Tyneside General Hospital

North Shields, United Kingdom

Location

Nottingham University Hospital NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

The Adam Practice

Upton, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Tom Wilkinson

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients will be randomised to one of two treatment groups (SNG001 or placebo). In Part 1 the ratio will be 4:1 and in Part 2 the ratio will be 1:1, both according to a pre-specified randomisation schedule. In Part 2, prior to randomisation to SNG001 or placebo, patients will be stratified into two groups; those with cold symptoms without a moderate COPD exacerbation (Group A), and those who have a moderate COPD exacerbation with or without cold symptoms (Group B). For both parts of the study, patients will be randomised according to a pre-specified randomisation schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: June 27, 2018
• Study Start: January 29, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

GB (16)