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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07082738
Registration number
NCT07082738
Ethics application status
Date submitted
11/06/2025
Date registered
24/07/2025
Date last updated
16/09/2025
Titles & IDs
Public title
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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Scientific title
A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)
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Secondary ID [1]
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D7860C00006
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Universal Trial Number (UTN)
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Trial acronym
PRESTO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD6793
Other interventions - Placebo
Experimental: Dose 1 of AZD6793 - Approximately 290 participants will be randomized to receive Dose 1 of AZD6793
Experimental: Dose 2 of AZD6793 - Approximately 290 participants will be randomized to receive Dose 2 of AZD6793
Experimental: Dose 3 of AZD6793 - Approximately 290 participants will be randomized to receive Dose 3 of AZD6793
Placebo comparator: Matching Placebo - Approximately 290 participants will be randomized to receive Matching Placebo
Treatment: Drugs: AZD6793
Oral dosage
Other interventions: Placebo
Oral dosage
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualised rate of moderate or severe COPD exacerbations
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Assessment method [1]
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The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
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Timepoint [1]
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From baseline up to 24 Weeks
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Secondary outcome [1]
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Time to first moderate or severe COPD exacerbation
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Assessment method [1]
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To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
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Timepoint [1]
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From baseline up to 24 Weeks
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Secondary outcome [2]
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Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations
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Assessment method [2]
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To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
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Timepoint [2]
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From baseline up to 24 Weeks
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Secondary outcome [3]
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Annualised rate of severe COPD exacerbations
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Assessment method [3]
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To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
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Timepoint [3]
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From baseline up to 24 Weeks
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Secondary outcome [4]
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Annualised rate of COPDCompEx events
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Assessment method [4]
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To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
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Timepoint [4]
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From baseline up to 24 Weeks
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Secondary outcome [5]
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Time to first COPDCompEx event
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Assessment method [5]
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To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
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Timepoint [5]
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From baseline up to 24 Weeks
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Secondary outcome [6]
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Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
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Assessment method [6]
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Change from baseline in pre-BD FEV1 at Week 12 and Week 24 compared to placebo
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Timepoint [6]
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From baseline to Week 12 and Week 24
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Secondary outcome [7]
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Change from baseline in post-bronchodilator (post-BD) forced expiratory volume in 1 second (FEV1)
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Assessment method [7]
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Change from baseline in post-BD FEV1 at Week 12 and Week 24 compared to placebo
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Timepoint [7]
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From baseline to Week 12 and Week 24
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Secondary outcome [8]
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Change from baseline in Breathlessness, Cough and Sputum Scale (BCSS) total score
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Assessment method [8]
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Change from baseline in BCSS total score over 24 Weeks compared to placebo. The BCSS is a 3-item questionnaire rating breathlessness, sputum, and cough on a 5 point Likert scale from 0 (no symptoms) to 4 (severe symptoms). The BCSS has a scoring range of 0-12 with higher scores indicative of greater COPD impact on health status.
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Timepoint [8]
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From baseline over 24 Weeks
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Secondary outcome [9]
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Change from baseline in COPD Assessment Test (CAT) total score
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Assessment method [9]
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Change from baseline in the CAT total score over 24 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.
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Timepoint [9]
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From baseline over 24 Weeks
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Secondary outcome [10]
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Change from baseline in St George's Respiratory Questionnaire (SGRQ) total and domain scores
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Assessment method [10]
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Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 24 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.
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Timepoint [10]
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From baseline over 24 Weeks
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Secondary outcome [11]
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Measurement of plasma concentrations of AZD6793 at specific timepoints
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Assessment method [11]
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To assess the pharmacokinetics (PK) of AZD6793 in participants with moderate to very severe COPD
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Timepoint [11]
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From baseline to Week 4, Week 12 and Week 24
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Eligibility
Key inclusion criteria
* Participant must be =40 years of age at the time of signing the informed consent.
* Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
* Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 = 25% to < 80% of predicted normal at Visit 2.
* Documented history of = 2 moderate or = 1 severe COPD exacerbations in the 12 months prior to screening.
* Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for = 3 months prior to screening.
* CAT score = 10 at Visit 1.
* Current or ex-smokers with a cigarette smoking history of = 10 pack-years.
* Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
* Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
* Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
* Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
* Significant left heart failure.
* Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
* Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
* History of another underlying condition that predisposes the participant to infections.
* History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
* Abnormal laboratory findings.
* Participants with evidence of active liver disease and/or evidence of chronic liver disease.
* Participants with history of HIV infection or who test positive for HIV.
* History of lung volume reduction surgery.
* Current or history of malignancy within 5 years before the screening visit.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/06/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/11/2027
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Actual
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Sample size
Target
1160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Cairns
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Research Site - Norwood
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Research Site - Osborne Park
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Research Site - South Brisbane
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Research Site - Wollongong
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Recruitment postcode(s) [1]
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4870 - Cairns
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Recruitment postcode(s) [2]
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5067 - Norwood
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Recruitment postcode(s) [3]
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6017 - Osborne Park
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment outside Australia
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Hajdúnánás
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Hungary
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NyÃregyháza-Sóstóhegy
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Hungary
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Törökbálint
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India
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Belagavi
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India
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Coimbatore
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India
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Dehradun
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India
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Dwarka
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India
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Hyderabad
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India
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Kochi
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India
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Mumbai
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India
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Nagpur
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India
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Vijayawada
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Italy
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Busto Arsizio
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Italy
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Cuneo
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Italy
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Milan
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Italy
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Monza
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Italy
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Statte
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Italy
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Telese Terme
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Fukuoka
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Japan
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Fukushima
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Japan
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Ginowan-shi
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Japan
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Japan
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Hamamatsu
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Izumi-shi
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Japan
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Kamakura
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Japan
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Kochi
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Minokamo Shi
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Japan
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Oita
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Japan
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Sagamihara-shi
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Sapporo
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Japan
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Shinjuku-ku
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Japan
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Tachikawa-shi
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Japan
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Toon-shi
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Japan
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Ube
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Japan
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Yokohama
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Mexico
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Chihuahua City
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Mexico
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Durango
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Mexico
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Guadalajara
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Mexico
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Mexico City
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Mexico
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Monterrey
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Lima
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Poland
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Bialystok
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Checiny
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Elblag
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Karczew
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Komorniki
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Ksawerów
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Lodz
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Plock
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Szczecin
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Warsaw
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Chuncheon
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Daegu
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Jeonju
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Seoul
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Wonju
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Benalmádena
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Spain
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Spain
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Madrid
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Mérida
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Santander
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Changhua
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Taiwan
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Taiwan
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Taiwan
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Turkey (Türkiye)
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Adana
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Bursa
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Izmit
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Kayseri
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Turkey (Türkiye)
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Mersin
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Ukraine
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Ukraine
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Ternopil
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Ukraine
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Uzhhorod
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United Kingdom
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Bradford
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Cottingham
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Glasgow
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Harrow
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London
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United Kingdom
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Newcastle upon Tyne
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Thetford
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United Kingdom
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Vietnam
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Hu?
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
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Trial website
https://clinicaltrials.gov/study/NCT07082738
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Dave Singh, MD
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Address
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0
Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
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Email
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0
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
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0
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0
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Phone
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0
1-877-240-9479
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Fax
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07082738
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