A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD

Summary

Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.

Eligibility

Inclusion Criteria:

* Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects
* Adult males and females, 40 to 80 years of age (inclusive) at screening.
* Current or former cigarette smokers with a ≥10 pack-year smoking history
* Established physician diagnosis of COPD with associated symptoms defined by the GOLD guidelines for ≥ 12 months of screening.
* FEV1 post-bronchodilator of 40% to 80% of predicted normal at Screening
* Current symptoms of COPD, including bronchitis and/or dyspnoea on moderate exertion at screening.

Exclusion Criteria:

* History of life-threatening COPD
* Chronic obstructive pulmonary disease exacerbation requiring oral or parenteral corticosteroids or hospitalisation within 3 months of Screening
* Other clinically active, physician diagnosed moderate to severe respiratory disorders that could interfere with study assessments or confound results (e.g., asthma, bronchiectasis, pulmonary fibrosis, interstitial lung diseases, bronchiolitis obliterans, lung cancer, cor pulmonale, pulmonary hypertension, uncontrolled sleep apnoea, active tuberculosis).

Other inclusion/exclusion eligibility criteria apply.

Conditions2

Interventions1

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