A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KIT2014, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Overview
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.
Detailed description
This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. The study will be conducted in 3 ascending dose cohorts.
Interventions
- Drug KIT2014
KIT2014 will be administered by inhalation with a nebuliser - Drug Placebo
Placebo will be administered by inhalation with a nebuliser
Primary outcome measures
- Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs) [Time frame: From first dose to post-treatment follow up visit on Day 9.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Novatrials — Charlestown
Identifiers
NCT: NCT07668518 · KIT2014-03