A Study to Investigate How Safe and Well Tolerated RV568 is in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01475292 | Completed Phase 2

• 2 other identifiers: RVH0062011-004031-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

RV568 is being developed as a possible treatment of diseases such as smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma. The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose strengths of RV568 and a placebo will be tested in this study, which will be given by inhaling a liquid suspension from a nebuliser once a day for 2 weeks.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Assessment of vital signs, ECG, adverse event assessment, clinical laboratory screening and spirometry.

  28 days

Secondary Outcomes (4)

• Plasma RV568 levels

  0,15,30,45 min and 1,2,4,6,8,10,12 & 24 hours post dose on Days 1 & 14, 0,1 & 2 hours post dose on Day 7 and one time point on Days 4, 21 & 28

• Assessment of lung function using a body plethysmograph

  2 week treatment period

• Assessment of markers of inflammation in sputum

  2 week treatment period

• Assessment of markers of inflammation in blood

  28 days

Study Arms (3)

RV568 treatment group low dose

EXPERIMENTAL

Drug: RV568

RV568 treatment group high dose

EXPERIMENTAL

Drug: RV568

Placebo treatment group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RV568 DRUG

RV568 50 ug administered via a nebuliser once daily for 14 days

RV568 treatment group low dose

Placebo DRUG

Placebo administered via a nebuliser once daily for 14 days

Placebo treatment group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 40-75 years inclusive at the time of signing the informed consent.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible with COPD for at least 1 year prior to screening.
• Severity of Disease: subjects who conform to the current severity classification for GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening (Post-salbutamol FEV1/FVC ratio of ≤ 0.70 and post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using ECCS reference equations)
• Demonstrated ability to use the I-neb AAD system at screening.
• Subject is a current or previous smoker with a smoking history of ≥ 10 pack years

You may not qualify if:

• A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation
• A history of \> 1 hospitalisation for COPD in the previous 2 years prior to screening.
• Evidence of cor pulmonale or clinically significant pulmonary hypertension or chronic (in the opinion of the Investigator) use of oxygen.
• Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening.
• Other respiratory disorders: Subjects with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases.
• Subjects with a history of chronic disease including, but not limited to, sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
• Previous lung resection or lung reduction surgery.
• Pregnant or nursing females.
• Any abnormal or clinically significant ECG or laboratory values that the Investigator considers would put the subject at risk through participation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included if the Investigator and the sponsor representative agree it is unlikely to introduce additional risk factors and will not interfere with study procedures.
• ALT \> 2 x ULN at the screening visit.
• A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody result, or positive test for HIV antibody at the screening visit (or within the 3 months prior to screening).
• Positive test for drugs of abuse at screening that cannot be satisfactorily explained by a prescription history (e.g., recent use of codeine tablets).
• History of alcohol abuse within the previous 6 months
• Has had major surgery, (requiring general anesthesia) within 6 weeks before the screening visit, or will not have fully recovered from surgery, or planned surgery through the end of the study
• Participated in any other clinical study of an NCE within 3 months, or in a study of a marketed drug within 1 month (or within 5 half-lives of the NCE or marketed drug, whichever is the longest) of first dose; or has participated in 4 studies in the previous 12 months.

Sponsors & Collaborators

• Respivert Ltd: lead

Study Sites (2)

Quintiles Drug Research Unit at Guy's Hospital

London, United Kingdom

Location

Medicines Evaluation Unit (MEU)

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Leonard Siew, MD

  Quintiles Drug Research Unit at Guy's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

GB (2)