Pulmonology: Clinical Studies Open For Enrollment
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Eligibility
- 12 years of age or older
- Asthma diagnosis for at least past 12 months
- Use of medium to high dose inhaled corticosteroids for at least 12 months as well as an additional asthma maintenance controller
- Two or more asthma exacerbations in the past 12 months
- Not using biologics in the past four months
- No severe COPD
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05329194
Principal Investigator
Dr. Sankaran Krishnan
Contact for Study Screening
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Eligibility
- Diagnosis of Cystic Fibrosis
- No history of transplant
- No exacerbations in past two weeks
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05639556
Principal Investigator
Dr. Allen Dozer
Contact for Study Screening
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Eligibility
- Male or female 29 – 85 years of age
- Able to tolerate nasal epithelial specimen collection
- Subject clinical history available for review by sponsor and regulatory agencies
- New nodule first identified on imaging < 90 days prior to nasal sample collection (index nodule)
- CT report available for index nodule
- Current or former smoker (>100 cigarettes in a lifetime)
- Pulmonary nodule ≤30 mm detected by CT
- Exclusion: Subject has undergone a diagnostic procedure for the management of their index nodule after the index CT and prior to enrollment, Active cancer (other than non-melanoma skin cancer), Prior primary lung cancer (prior non-lung cancer acceptable), Prior participation in this study (i.e., subjects may not be enrolled more than once), Current active treatment with an investigational device or drug (patients in trial follow up period are okay if intervention phase is complete), Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient’s nodule and Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy (e.g., genomic or proteomic blood tests) other than clinically validated risk calculators
Enrollment Status: Enrolling
Principal Investigator
Dipak Chandy, MD
Contact for Study Screening
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Eligibility
- Male or female at least 18 years of age
- Have a body mass index of ≥18 kg/m2
- Have findings consistent with bronchiectasis per computerized tomography (CT) (or high-resolution CT [HRCT])
- Have microbiological evidence of pulmonary P. aeruginosa infection from a sputum sample within the last 24 months. Sputum cultures may be repeated on up to 3 occasions during the Screening Period to document P. aeruginosa presence if the initial sputum culture is negative
- Exclusion Criteria: for matched healthy controls; Have a history of lung transplantation, have a history of α1-antitrypsin deficiency, have a history of cystic fibrosis and have previously received 1 or more doses of AP-PA02 in any context, including, but not limited to, prior participation in study AP-PA02-101, prior enrollment in this study, or emergency use (with or without prior authorization)
Enrollment Status: Enrolling
Study Information
EudraCT 2021-006733-19
Principal Investigator
John Welter, MD
Contact for Study Screening
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Eligibility
- Male or female ≥ 40 years of age
- Documented diagnosis of COPD for at least one year prior to enrolment
- Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment
- Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment
- Smoking history of ≥ 10 pack-years
- CAT total score ≥10, with each of the phlegm (sputum) and cough items with a score ≥ 2
- Exclusion Criteria
- Clinically important pulmonary disease other than COPD
- Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms
- Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18
- Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study
- COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization
- Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection
- Suspicion of, or confirmed, ongoing SARS-CoV-2 infection
Enrollment Status: Open to Enrollment
Study Information
EudraCT 2021-003797-30
Principal Investigator
Sankaran Krishnan, MD
Contact for Study Screening
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Eligibility
- Healthy Male or female, age 18-55 years
- Body weight greater than or equal to 50 kg and body mass index (BMI) between 16-32 kg/m2, inclusive
- The participant has a forced expiratory volume in one second (FEV1) of at least 80% predicted
- The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening
- Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol
- Exclusion Criteria
- Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter
- Current evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any other medical condition that, in the Investigator’s judgement, would impact the participant’s safety or interpretation of study results
- Any of the following abnormalities in clinical laboratory tests at screening, confirmed by a single repeat if deemed necessary:
- An estimated glomerular filtration rate value <80 mL/minute/1.73 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >1.5×upper limit of normal (ULN)
- Total bilirubin >1.5×ULN. (Participants with a history of Gilbert’s syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is less than the ULN)
- Hematological values outside the normal reference range for local laboratory results unless regarded as clinically not significant
Enrollment Status: Open to Enrollment
Study Information
ClinicalTrials.gov | NCT06237335
Principal Investigator
Allen Dozor, MD
Contact for Study Screening
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Eligibility
- The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions.
- Subjects aged 18 years or older at the time of Informed Consent
- A confirmed diagnosis of CF as defined by clinical signs and symptoms of CF and at least one of the following:
- A historical sweat chloride value ≥60 mmol/L
- Two copies of a disease-causing mutation in the CFTR gene
- Clinically stable in the opinion of the Investigator
- Percent predicted FEV1 ≥50% and ≤100% of the predicted normal for age, gender, and height at Visit 1 (Screening)
- Resting oxygen saturation ≥92% on room air at Visit 1 (Screening)
- Exclusion Criteria
- Initiation of any new chronic therapy (e.g., CFTR modulator, hypertonic saline, inhaled antibiotic) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to the first dose (Visit 2 [Day 0])
- Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness 14 days prior to the first dose (Visit 2 [Day 0]) that, in the opinion of the Investigator, may confound study results
- Treatment for Burkholderia cenocepacia, Burkholderia dolosa, or Nontuberculosis Mycobacteria infection within 3 months prior to the first dose (Visit 2 [Day 0])
- Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to the first dose (Visit 2 [Day 0])
- History of or listed for solid organ transplantation
- Any condition (including a history or current evidence of substance abuse or dependence, uncontrolled asthma, or is considered to be immunocompromised) that, in the opinion of the Investigator, would impact a subject’s ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB407
- An active oral herpes infection 30 days prior to the first dose (Visit 2 [Day 0])
- Has received a vaccine within 72 hours prior to the first dose (Visit 2 [Day 0]) or has a planned vaccination during the treatment period
- Women who are pregnant or nursing
- Subject who is unwilling to comply with contraception requirements per protocol
- Clinically significant abnormalities of hematology or chemistry testing at Screening Visit (Visit 1) that the Investigator believes may interfere with the assessment of safety and/or efficacy of the study treatment
- Subject has a known hypersensitivity to inhaled glycerol
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator
- Bronchoscopy participants only: Unable to tolerate bronchoscopy procedure and airway sampling, in the opinion of the Investigator
Enrollment Status: Open to Enrollment
Study Information
ClinicalTrials.gov | NCT05095246
Principal Investigator
John Welter, MD
Contact for Study Screening
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Eligibility
- Male or Female ≥18 years
- Clinical history consistent with bronchiectasis and investigator confirmed diagnosis by computed tomography (CT) scan
- History of pulmonary exacerbations requiring antibiotic treatment in the last 12 months before Visit 1:
- at least 2 pulmonary exacerbations, or
- at least 1 exacerbation and an SGRQ Symptoms score of >40
- Exclusion Criteria
- Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation
- Allergic bronchopulmonary aspergillosis being treated or requiring treatment
- Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
Enrollment Status: Open to Enrollment
Study Information
ClinicalTrials.gov | NCT06872892
Principal Investigator
John Welter, MD
Contact for Study Screening