Anoro + Arnuity for COPD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two FDA-approved drugs, Anoro Ellipta and Arnuity Ellipta, to assess their impact on lung health in people with COPD, a lung disease that makes breathing difficult. Researchers will use a special imaging test called Hyperpolarized Xenon-129 MRI (HXe MRI) to closely examine lung function. The aim is to demonstrate that this imaging method can guide treatment plans and identify new ways to improve lung health. Individuals diagnosed with COPD and a history of alpha 1 anti-trypsin deficiency may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that hyperpolarized xenon-129 MRI is safe for assessing lung health in COPD patients?
Research shows that Anoro Ellipta is approved for treating chronic obstructive pulmonary disease (COPD). Studies have found it is generally well-tolerated, with manageable side effects. The European Medicines Agency identified no major safety concerns with Anoro Ellipta. The most common side effects include sore throat, sinus infection, and chest pain.
For Arnuity Ellipta, which is not specifically approved for COPD, safety reviews have found no new safety issues. However, people with COPD using inhaled Arnuity have shown an increased risk of pneumonia. As a corticosteroid, it helps reduce swelling in the lungs.
Both treatments have been used in people before. Anoro is already approved for COPD, and Arnuity's safety data suggests it is generally safe, though some risks exist. Participants in this trial can consider this information when deciding whether to join.12345Why are researchers excited about this trial?
Researchers are excited about the combination of Anoro Ellipta and Arnuity Ellipta for COPD because these inhalers target the condition in a complementary way. Anoro Ellipta is a dual bronchodilator that combines two active ingredients to relax and open the airways, while Arnuity Ellipta is an inhaled corticosteroid that reduces inflammation in the lungs. This combination has the potential to provide a more comprehensive treatment by addressing both airway constriction and inflammation, unlike many current treatments that focus on just one aspect. Additionally, the use of hyperpolarized Xenon-129 MRI in the study could offer new insights into lung function and the effectiveness of these combined therapies.
What is the effectiveness track record for Anoro and Arnuity in treating COPD?
Research shows that Anoro Ellipta, which participants in this trial will receive first, can improve lung function in people with COPD. Studies indicate it can increase lung capacity, measured by the forced expiratory volume in one second (FEV1), by about 167 ml compared to a placebo. This improvement helps patients breathe more easily over time.
After a washout period, participants will receive Arnuity Ellipta, which also manages COPD symptoms, although most research focuses on its use for asthma. Patients often prefer the Ellipta inhaler for its ease of use. Both treatments have FDA approval and are designed to alleviate breathing problems related to COPD.46789Who Is on the Research Team?
Yun M Shim, MD
Principal Investigator
University of Virginia
Kun Qing, PhD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for adults with COPD, a lung condition that makes it hard to breathe. Participants must have specific breathing test results (FEV1/FVC < 70%) and may have alpha-1 antitrypsin deficiency. It's not for those with asthma, interstitial lung disease, pulmonary vascular disease or who can't undergo MRI or other tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Anoro for 30 days, followed by a 3-day washout, then Arnuity for 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anoro Ellipta
- Arnuity Ellipta
- Hyperpolarized Xenon-129 MRI
Trial Overview
The study tests how well two FDA-approved drugs, Anoro Ellipta and Arnuity Ellipta, improve lung health in COPD patients using traditional methods plus a new type of MRI called Hyperpolarized Xenon-129 MRI. This aims to establish HXe MRI as a tool for assessing treatment effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All subjects will be assessed with hyper polarized xenon-129 MRI, pulmonary function test, quality of life measures (BDI, TDI, SGRQ, CRQ, BODE, GOLD), and blood test. Intervention: All subjects will received Anoro one puff once a day for 30 days first, then 3 day washout, then Arnuity 250 microgram one puff twice a day for 30 days to complete the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Citations
ANORO ELLIPTA Efficacy & Clinical Information
ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ANORO is NOT for the relief of acute bronchospasm or ...
Umeclidinium Bromide/Vilanterol Trifenatate (Anoro Ellipta)
In two of the studies, COPD exacerbation led to more withdrawals from the UMEC/VI (6.3% and 11%) than the TIO group (4.9% and 5.6%), while a third study ...
GSK presents efficacy data for Anoro® Ellipta® in COPD ...
These efficacy data demonstrate the improvement in lung function that can be achieved in patients with moderate COPD when changing treatment ...
Anoro Ellipta (previously Anoro) - European Medicines Agency
Results showed that Anoro Ellipta improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Anoro Ellipta also ...
5.
israelpharm.com
israelpharm.com/faq/how-effective-is-anoro-ellipta-for-copd-based-on-current-clinical-trial-outcomes/Effectivity of Anoro Ellipta for COPD Management
Based on current clinical data, Anoro Ellipta may help improve lung function and reduce symptoms in adults with COPD, but individual results vary and it is not ...
Risks & Side Effects
ANORO ELLIPTA is approved for use in those suffering from COPD. It is not approved as a medication for asthma. See Full Safety & Prescribing Information.
anoro® ellipta - accessdata.fda.gov
ANORO ELLIPTA is only approved for use in chronic obstructive pulmonary disease (COPD). ANORO ELLIPTA is. NOT approved for use in asthma. ANORO ELLIPTA can ...
ANORO ELLIPTA Inhaler | A COPD Treatment
INDICATION & IMPORTANT SAFETY INFO. INDICATION. ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ANORO is ...
Adverse Reactions Associated With ANORO ELLIPTA
Find clinical data statistics about the incidence of adverse reactions associated with ANORO ELLIPTA (umeclidinium & vilanterol inhalation powder) for COPD.
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