chronic obstructive pulmonary disease (COPD) MedDRA version: 14.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: RV568
Product Code: RV568
Pharmaceutical Form: Inhalation solution
Current Sponsor code: RV568
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
RespiVert Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 40-75 years inclusive at the time of signing the informed consent. 2. Capable of giving written informed consent. 3. Patients 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. 4. Patients 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. • Post-salbutamol FEV1 = 40 % and = 80 % of predicted normal values calculated using ECCS reference equations. 5. Demonstrated ability to use the I-neb AAD system at screening. 6. Patient is a current or previous smoker with a smoking history of = 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent). 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation. 2. A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening visit 1. 3. Evidence of cor pulmonale, clinically significant pulmonary hypertension and chronic use of oxygen. 4. Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening. 5. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases. 6. Patients 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. 7. Previous lung resection or lung reduction surgery. 8. Pregnant or nursing females. 9. Any abnormal or clinically significant ECG or lab values that the Investigator considers would put the subject at risk through participation. 10. 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). 11. Positive test for drugs of abuse at screening that cannot be satisfactorily explained by a prescription history (e.g., recent use of codeine tablets). 12. History of alcohol abuse within the previous 6 months. 13. Has had major surgery, (requiring general anesthesia) within 6 weeks before screening visit 2, or will not have fully recovered from surgery, or planned surgery through the end of the study. 15. A disclosed history, or one known to the Investigator, of significant noncompliance in previous investigational studies or with prescribed medications. 16. Allergy to any of the active or inactive ingredients in the study medication, or history of drug, or other allergy that, in the opinion of the Investigator or RespiVert medical monitor, would contraindicate their participation. 17. Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if study participation would result in blood loss in excess of 500 mL in a 3 month period. 18. Patient is mentally or legally incapacitated. 19. Has any condition or are taking a medication that, in the opinion of the Investigator, would make participation not be in the best interest (i.e., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments. 20. Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of repeat inhaled doses of RV568 for 14 days in patients with moderate to severe stable COPD.;Secondary Objective: - To characterise the pharmacokinetic parameters of RV568 following repeat administration of inhaled RV568 for 14 days in patients with moderate to severe stable COPD. - To evaluate the effect of treatment with repeat inhaled doses of RV568 for 14 days on pharmacodynamic markers in patients with moderate to severe COPD. ;Primary end point(s): Safety and tolerability: Adverse events (AEs), 12-lead electrocardiogram (ECG; including QTc(B), QT, QRS, PR and ventricular rate), vital signs (blood pressure and heart rate), clinical laboratory evaluations (haematology, clinical chemistry, urinalysis), spirometry (forced expiratory volume in 1 second, forced vital capacity and peak expiratory flow), mucus and cough monitoring and withdrawals for worsening COPD. ;Timepoint(s) of evaluation of this end point: AEs: Day -1 to Day 28 (follow-up) 12-lead ECG: screening, Days 1 and 14 at pre-dose, 0.5, 1 and 4 h post-dose, Day 15 and Day 28 Vital signs:screening, Days 1 and 14 at pre-dose, 0.5, 1 and 4 h post-dose, Day 15 and Day 28 Clinical laboratory evaluations: screening, Day -1 and Day 28 Spirometry: screening, pre-dose on Days 4, 7, 9 and 12, Days 1 and 14 at pre-dose, 10 minutes and 1, 4 and 24 h and Day 28 Peak expiratory flow: daily from Day 1 to Day 14 Mucus and cough monitoring: daily from Day 1 to Day 14 Withdrawals for worsening COPD: from Day 1 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Derived pharmacokinetic parameters for RV568 including AUC(0-t), AUC(0-inf), Ctrough, Cmax, t1/2, Tmax, CL/F, accumulation ratio following single and repeat dosing. Plethysmography measures: IC, RV, FRC, TLC, SVC, TGV, plus airway resistance (Raw) and specific airway conductance (sGaw). ;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters: Days 1 and 14 at pre-dose, 15, 30 and 45 minutes post-dose and 1, 2, 4, 6, 8, 10, 12 and 24 h post-dose, Day 2, Day 4 pre-dose, Day 7 at pre-dose and 1 and 2 h post-dose, Day 15, Day 21 and Day 28 Plethysmography measures: screening, Day -1 and Day 14 pre-dose | — |
Countries
United Kingdom
Contacts
Public ContactClinical Development
RespiVert Ltd
Outcome results
None listed