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About
This is a phase II, randomised, double blind, placebo controlled, complete block, three way crossover study to investigate treatment with nebulised RPL554 and tiotropium together in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The purpose of this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when used in combination with a long acting anti-muscarinic receptor antagonist (tiotropium) whilst dosing the RPL554 to steady state blood levels. It is planned to randomise up to 30 patients to have 24 evaluable patients at one study centre. In each treatment period, patients will receive an open label dose of tiotropium from a dry power inhaler (DPI) followed immediately by a double blind dose of either RPL554 6mg, 1.5mg or placebo (depending on treatment sequence) from a nebuliser in the morning on Day 1, Day 2 and Day 3. The dose of RPL554 or placebo will be repeated in the evening on Day 1 and Day 2; there will not be an evening dose on Day 3.
Enrollment
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Volunteers
Inclusion criteria
Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
Male or female aged between 40 and 75 years inclusive, at the time of informed consent.
If male: must agree to meet the following from the first dose up to 1 month after the last dose of study treatment:
If female: either be:
Of non-childbearing potential defined as being:
Of childbearing potential and agreeing to use a highly effective method of contraception until completion of the end of study visit.
Have a 12-lead ECG recording at screening and randomisation (pre-dose in Treatment Period 1) showing the following:
Have a screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis which shows no abnormality which indicates a significant impairment of patient safety or which may significantly impairs interpretation in the opinion of the Investigator including:
Capable of complying with all study restrictions and procedures including ability to use the study nebuliser and HandiHaler® DPI correctly.
Body mass index (BMI) between 18 and 33 kg/m2 (inclusive) with a minimum weight of 45 kg.
COPD diagnosis: Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli and MacNee, 2004) with symptoms compatible with COPD for at least 1 year prior to screening.
Post-bronchodilator (four puffs of salbutamol) spirometry at screening:
Clinically stable COPD in the 4 weeks prior to screening and randomisation (pre-dose in Treatment Period 1).
A chest X-ray (post-anterior) at screening, or in the 12 months prior to screening showing no abnormalities, which are both clinically significant and unrelated to COPD.
Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
Smoking history of ≥10 pack years.
Capable of withdrawing from long acting bronchodilators for the duration of the study, and short acting bronchodilators for 8 hours prior to spirometry.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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