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More info
You can access this
clinical trial
if you have
Chronic Obstructive Pulmonary Disease Moderate
and you are
between 40 and 75
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: 1.5 mg RPL554 plus tiotropium
  • Drug: 6 mg RPL554 plus tiotropium
  • Drug: Placebo plus tiotropium
Tris trial is registered with FDA with number: NCT03028142. The sponsor of the trial is Verona Pharma plc and it is looking for 30 volunteers for the current phase.
Official trial title: