Clinical Research Studies
We have several research trials in progress. Ask your provider if you qualify for any of our studies or contact the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
Available Clinical Trials:
Below are the currently available clinical trials at Colorado ENT & Allergy:
CLINICAL TRIAL: Solairia Asthma Research Study
Asthma research needs you! A clinical research study to evaluate an investigational therapy for severe asthma is enrolling now.
Those who qualify may receive:
- Reimbursement for selected expenses.
- No-cost study-related care.
- No-cost study drug.
We are looking for adults who:
- are between 18 and 80 years of age.
- Have had an asthma diagnosis for more than 2 years.
- Have required corticosteroids at least twice over the last 12 months to control your asthma.
You may qualify for a Clinical Trial with Colorado ENT & Allergy. Please call or email the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
CLINICAL TRIAL: Calm the Cough
A persistent cough is more than an annoyance. It can seriously impact your quality of life and social interactions and may cause you to feel isolated or anxious. This study center is running a clinical research study to see how safe an investigational drug is and whether it works in people with refractory chronic cough (RCC), including unexplained chronic cough.
We need to enroll a wide variety of participants because RCC and
investigational drugs may affect people differently based on their age, sex, gender, and race and/or ethnicity.
We are looking for adults who:
- are between 18 and 80 years of age
- have had a cough for at least 1 year that did not improve or only partially improved after medical evaluation and prescribed or over-the-counter treatments.
You may qualify for a Clinical Trial with Colorado ENT & Allergy. Please call or email the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
CLINICAL TRIAL: Chronic Rhinosinusitis with Nasal Polyps
We are looking for participants with Chronic Rhinosinusitis with Nasal Polyps on Background Intranasal Corticosteroids (J2T). Qualifications include:
- ≥18 years of age
- Physician-diagnosed Chronic Rhinosinusitis with Nasal Polyps
- Ongoing symptoms for at least 8 weeks
- Prior treatment within the last 2 years
If you meet these qualifications, you may qualify for a Clinical Trial with Colorado ENT & Allergy. Please call or email the Clinical Research Department for more information:
CLINICAL TRIAL: Adolescent Chronic Rhinosinusitis without Nasal Polyps
We are looking for adolescent participants with Chronic Rhinosinusitis without Nasal Polyps. Qualifications include:
- 12 to 17 years
- history of Chronic Rhinosinusitis equal to or greater than 12 weeks
- nasal congestion or nasal discharge (anterior and/or posterior nasal discharge)
- facial pain or pressure
- reduction or loss of smell
If you meet these qualifications, you may qualify for a Clinical Trial with Colorado ENT & Allergy. Please call or email the Clinical Research Department for more information:
CLINICAL TRIAL: NAZARE Study for Asthma
Do you experience severe asthma symptoms despite existing treatments? You may qualify for a clinical trial with Colorado ENT & Allergy. Please call or email the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
CLINICAL TRIAL: ARIA Study for Adolescents with Asthma
The ARIA study evaluates an inhaled study drug that consists of a combination of 3 medicines. Please call or email the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
CLINICAL TRIAL: Pfizer Asthma Biologic Treatments
Pfizer is working closely with doctors to see if a potential targeted steroid-free treatment can help people with inadequately controlled moderate-to-servere asthma get better control of their symptoms.. Please call or email the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
CLINICAL TRIAL: Inspire Medical Research Study
If you are undergoing implant of the Inspire Upper Airway System for the treatment of Obstructive Sleep Apnea, you may be eligible to participate in a research study. Please call or email the Clinical Research Department for more information:
(719) 867-7804 or CENTAresearch@ColoradoENT.com
What are Clinical Trials?
Clinical trials pioneer disease prevention, detection, and treatment approaches and serve as the foundation for medical advancements.
Participants in clinical trials, especially those with specific health conditions, contribute significantly to developing novel treatments and a deeper comprehension of diseases, potentially steering toward cures. Additionally, in appreciation for their involvement, these participants often receive the latest investigational treatments free of charge and possible compensation for their time and travel expenses.
Furthermore, clinical trials signify a beacon of hope for numerous individuals, providing a chance to benefit from cutting-edge treatments and assist researchers in enhancing healthcare outcomes for future generations.
The Clinical Research Department bridges the specialties of ENT, Asthma, Allergy, and Immunology to provide a comprehensive specialty clinic serving both adults and pediatrics with a standard of care and clinical research study options.
Importance of Clinical Trials:
Clinical trials:
- are critical for innovative discoveries and medical breakthroughs
- help create new treatments and advance understanding of disease that can lead to a cure
- give you access to experimental, cutting-edge treatment options
- put your rights, safety, and well-being first
- Clinical Trials need YOU
Clinical Research Department:
The Clinical Research Department (CRD) is a dedicated unit with full-time staff and committed space to include exam rooms and a procedure/treatment room. The CRD Workroom houses all study materials in accordance with Good Clinical Practice guidelines to include locked, study-identified cabinets with controlled access. The Clinical Research Department houses a Pharmaceutical Grade, Temperature-Controlled Refrigerator, -20°C Freezer, Binocular Microscope, Dry Ice and Storage, Horizon 24 Flex Centrifuge, Lab Precision Scale, Phlebotomy Station, Electrocardiogram Units, Upright/ Low-Dose Radiation CT scanner, Portable Aspirator Units, Vital Sign Monitors, Health O Meter Digital Physician Scales, Audiology Testing Booths, and a Stryker© Nasal Endoscopy suite providing image-guided recording for endoscopic procedures.
Additionally, for Study Sponsors and CROs, the Clinical Research Department provides monitor space, Wi-Fi, Faxing/Scanning capabilities, rapid query resolution, CTA and budget 2-week turnaround and Central IRB access. There are 12 Board-Certified Physicians with over 20 years of clinical research experience in Adult and Pediatric Ear, Nose, Throat, Asthma, Allergy, Immunology, Biologics, and Sleep Medicine clinical trials. Additionally, 3 Doctors of Audiology provide comprehensive diagnostic audiological evaluations.
Clinical Research Department Team:
Colorado ENT & Allergy physicians support and encourage clinical trials in partnership with standard of care for each patient and work closely with highly skilled, experienced and ACRP-certified Clinical Research Coordinators who focus on patient rights and safety, continued education, recruitment, and protocol compliance to ensure successful study outcomes.
Furthermore, physicians and Clinical Research Coordinators are GCP-trained and certified. Clinical Research Coordinators are IATA-certified and trained in lab prep, processing, and biopsy collection. They are also certified to perform ECG, CLARIO MasterScope, ePRO, spirometry, pulmonary function testing, exhaled nitric oxide testing, and CPR.
Past Clinical Trials
Studies in the follow-up phase (non-enrolling):
- Obstructive Sleep Apena
- Loss of Smell (Cyrano)
- Swollen Sinuses and Nasal Polyps
- Severe Asthma
- Alternative to Sinus Surgery
- Chronic Cough
- Asthma Control for Adult and Adolescent Patients
- Ongoing hives
- Adult and adolescent participants with severe asthma
- Adolescents with severe uncontrolled asthma with an eosinophilic phenotype
- Treatment of Septal Swell Bodies for Airway Obstruction
- Severe Chronic Rhinosinusitis with Nasal Polyps
- Patients with Chronic Rhinitis
- Frequent Sinus Infections
- Inadequately Controlled Asthma
- Allergic and Nonallergic Chronic Rhinitis (BIOKLEAR)
Past clinical trials (studies effective since Nov 2020):
- Adults with Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments
- Adults with Acquired Sensorineural Hearing Loss
- Adults for Xerostomia
- Adults with airway inflammation through assessments of lung function, mucus plugging, and other lung imaging parameters
- Adults with Chronic Rhinosinusitis (CRS) With or Without Nasal Polyps
- Adults with Chronic Tympanic Membrane Perforation
- Adults with SPEECH-IN-NOISE HEARING IMPAIRMENT
- Adults with unilateral subjective tinnitus
- Adults with Chronic Rhinitis
- Adults with frontal sinus ostium following in-office bilateral balloon dilation
- Adults with Sensorineural Hearing Loss
- Adults with Chronic Rhinosinusitis with or without the presence of nasal polyps
- ClariFix Rhinitis
- Quality of Life Impact and Symptoms after Treatment of Using Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
- Intratympanic Injection in Adults with Stable Sensorineural Hearing Loss
Positive Trials Results
CLINICAL TRIAL: Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma
PUBLISHED 2 May 2025
Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.
KALOS and LOGOS were replicate, randomised, double-blind trials designed to investigate Breztri as a potential treatment for asthma.1,2 The trials evaluated the efficacy and safety of Breztri versus maintenance treatment with ICS/LABA in adults and adolescents with uncontrolled asthma.1,2
Asthma is a common, chronic respiratory disease characterised by inflammation and muscle tightening in the airway (bronchoconstriction), which can make it difficult to breathe.3 As many as 262 million people worldwide are affected by asthma,3 and it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life.4,5
Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.”
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that Breztri could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.”
There were no new safety or tolerability signals identified for Breztri in KALOS or LOGOS.
Full results from the two Phase III trials will be shared with regulatory authorities and presented at an upcoming medical meeting.
Breztri is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide including the US, EU, China and Japan.
Notes
Asthma
Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide,3 including over 25 million in the US.6 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death.3,7 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life.4,5
KALOS and LOGOS Phase III trials
KALOS and LOGOS are replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BGF (320/28.8/9.6μg and 320/14.4/9.6μg) compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in an Aerosphere inhaler) and Symbicort pressurised metered-dose inhaler (pMDI).1,2 KALOS and LOGOS included approximately 4,400 randomised patients.
The trial design was optimised to evaluate the 320/28.8/9.6μg dose of BGF. The primary efficacy endpoints for the two individual trials were a change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 and trough FEV1 over 12-24 weeks and over 24 weeks.1,2
In addition to the two registrational trials (KALOS and LOGOS), two qualifying trials, LITHOS and VATHOS, also met their primary endpoints.8,9 LITHOS and VATHOS included approximately 1,000 randomised patients.
Breztri/Trixeo Aerosphere
Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Breztri Aerosphere in Japan, China and the US, and Trixeo Aerosphere in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an ICS, and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat adults with COPD in more than 80 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 5.5 million patients globally in 2024.10
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.
AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
References
1. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1. [Last accessed: May 2025].
2. Clinicaltrials.gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4. [Last accessed: Mayl 2025].
3. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf. [Last accessed: May 2025].
4. Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma. 2019 Mar;56(3):332-340.
5. Buhl R, et al. One-year follow up of asthmatic patients newly initiated on treatment with medium- or high-dose inhaled corticosteroid-long-acting β2-agonist in UK primary care settings. Respir Med. 2020 Feb: 162:105859.
6. U.S. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. [Online]. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. [Last accessed: May 2025].
7. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.
8. Clinicaltrials.gov. A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT05755906?limit=25&term=LITHOS&rank=1. [Last Accessed: May 2025].
9. Clinicaltrials.gov. A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma (VATHOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT05202262?limit=25&term=VATHOS&rank=1. [Last Accessed: May 2025].
10. AstraZeneca Data on File. 2025. REF-270910.
CLINICAL TRIAL: Switching to depemokimab in participants with severe asthma
- Publication of Study Results in American Journal of Respiratory And Critical Care Medicine:
We are very pleased to inform you that you can now access the published results of the NIMBLE study in the American Journal of Respiratory and Critical Care Medicine via the following link:
