Breaking News
November 19, 2017 - Researchers identify possible genetic basis for coronary artery disease
November 19, 2017 - Stress experienced by emergency call handlers has negative impact on psychological health
November 18, 2017 - New cancer cell screening is improving childhood leukaemia treatment
November 18, 2017 - Groundbreaking study identifies protein as potential factor in cancer metastasis
November 18, 2017 - New model to test effectiveness of existing and potential CF therapies
November 18, 2017 - Staying Active May Lower Odds for Glaucoma
November 18, 2017 - Potential new autism drug shows promise in mice
November 18, 2017 - Some states roll back ‘retroactive Medicaid,’ a buffer for the poor — and for hospitals
November 18, 2017 - Selectively deleting stem cell factor promotes recovery after TBI in mice
November 18, 2017 - Breakthrough research brings new procedure closer to helping patients with blood cancer
November 18, 2017 - Dr Peter Simpson Appointed to SLAS Board of Directors
November 18, 2017 - Friendships between young children can protect against ADHD
November 18, 2017 - Old World monkeys could hold key to stop progression of rheumatoid arthritis
November 18, 2017 - Harris Health System RNs named among 20 Outstanding Nurses for 2017
November 18, 2017 - Old World monkeys could be key to a new, powerful rheumatoid arthritis therapy
November 18, 2017 - Mount Sinai researchers identify new therapeutic target for ER+ breast cancer
November 18, 2017 - Age, CRP levels predict success in tapering of biologics in rheumatoid arthritis patients
November 18, 2017 - New dye could be used to observe electrical activity of neurons in the brain
November 18, 2017 - New study further validates use of vaginal progesterone to decrease risk of preterm birth
November 18, 2017 - Russian researcher determined range of reference values for boron in the human body
November 18, 2017 - ‘What the Health?’ Tax bill or health bill?
November 18, 2017 - Could Your Cat Give You ‘Bird Flu?’
November 18, 2017 - Vitamin D Linked to Fertility Outcomes in ART
November 18, 2017 - Neuroscientists identify genetic changes in microglia in a mouse model of neurodegeneration and Alzheimer’s disease
November 18, 2017 - Tax reform proposal could impact care for older Americans
November 18, 2017 - PCSK9 inhibitor offers clinical benefit to patients with peripheral artery disease
November 18, 2017 - Researchers receive £1.3 million to develop sight-saving imaging technology
November 18, 2017 - Novel buckypaper sensor could pave way for high-performance, affordable wearable technology
November 18, 2017 - Despite ACA cost protections, most adolescents skip regular checkups
November 18, 2017 - Stem cell treatment allows paraplegic rats to walk and regain sensory perception
November 18, 2017 - HTC analytical conference comes to the UK
November 18, 2017 - Face It: Drinking, Smoking Takes Toll on Looks: MedlinePlus Health News
November 18, 2017 - New research shows where in the brain the earliest signs of Alzheimer’s occur
November 18, 2017 - Philips announces launch of global movement to raise awareness for COPD
November 18, 2017 - University of Bristol awarded grant to reduce antibacterial drug resistance in Thailand
November 18, 2017 - New oxytocin chemical sensor could be first step towards early diagnosis of autism
November 18, 2017 - Study shows how naïve T-cells may affect tumor immunity and immunotherapy
November 18, 2017 - New studies highlight importance of cardiorespiratory fitness to reduce CVD risk
November 18, 2017 - Study finds medical cannabis is effective at reducing opioid addiction
November 18, 2017 - Specially tailored, ultrafast light pulses can trigger neurons to fire in different patterns
November 18, 2017 - Decrease in sunshine linked to rising incidence of Rickets
November 18, 2017 - Harnessing social media big data to fight against prescription drug crisis
November 18, 2017 - Researchers find way to switch tumor cells between 2D and 3D morphology
November 18, 2017 - FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
November 18, 2017 - Adolescents underreport amphetamine use, likely unaware that adderall is amphetamine
November 18, 2017 - Study reveals a reduced risk of teenage eczema in breastfed babies
November 18, 2017 - Separating side effects could pave way for safe, effective pain medications
November 18, 2017 - Gut bacteria at young age can contribute to MS disease onset and progression, study suggests
November 18, 2017 - Environmental triggers may play role in development of Lupus
November 18, 2017 - Review looks into conventional versus new treatment modalities in orthodontic pain management
November 17, 2017 - FDA Alert: Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall
November 17, 2017 - For older women, every movement matters
November 17, 2017 - Talking-based therapy could transform aftercare for cancer survivors
November 17, 2017 - Olympus IXplore SpinSR10 imaging system enables researchers to observe fine details in live cells
November 17, 2017 - Study explores reasons for underrepresentation of minorities in genetic cancer research
November 17, 2017 - California firm running physician practices is closing down as scrutiny ramps up
November 17, 2017 - BMI not valid measure of obesity in postmenopausal women, study shows
November 17, 2017 - Vaginal progesterone decreases the risk of premature birth in women with short cervix
November 17, 2017 - Pricey ER Tests for Chest Pain Often Unnecessary
November 17, 2017 - ‘Old’ Lungs May Be Good Transplant Options: MedlinePlus Health News
November 17, 2017 - How not to gain weight over the holidays
November 17, 2017 - Researchers map first-ever proteome of healthy human heart
November 17, 2017 - Drug used to prevent and treat malaria may also be effective for Zika virus
November 17, 2017 - One in 20 children still receiving codeine to treat pain despite warning from federal regulators
November 17, 2017 - Improving clinical trials with machine learning
November 17, 2017 - Experts identify mental exercise program that can reduce risk of dementia
November 17, 2017 - Just-in-time 3-D implants set to transform tumor surgery
November 17, 2017 - Skin patch offers hope for people with peanut allergy
November 17, 2017 - Scientists identify biomarkers that predict risk of death in Ebola patients
November 17, 2017 - Heart attack, stroke patients have improved outcomes when statins are prescribed after discharge
November 17, 2017 - Majority of people do not understand link between obesity and cancer, study shows
November 17, 2017 - Deep vein thrombosis accurately diagnosed by GPs trained in compression ultrasonography
November 17, 2017 - New Kevlar-based hydrogel recreates the magic of natural cartilage
November 17, 2017 - FDA approves first adjuvant treatment to reduce risk of kidney cancer recurrence
November 17, 2017 - Foods made with biofortified corn flour and eggs retain vitamin A after cooking
November 17, 2017 - Integrated Care Winning the Day for Healthcare Companies
November 17, 2017 - CPAP may be superior to gastric banding for severe sleep apnea
November 17, 2017 - New pain relievers reduce opiate overdose risk
November 17, 2017 - Brain astrocytes could play key role in pathogenesis of Alzheimer’s disease
November 17, 2017 - Researchers test whether LVAD surgery could reverse frailty in older adults with heart failure
CHEST: Novel Agent Boosts Quality of Life in COPD

CHEST: Novel Agent Boosts Quality of Life in COPD

image_pdfDownload PDFimage_print

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • Revefenacin, an investigational long-acting nebulized drug for chronic obstructive pulmonary disease (COPD), improved patient quality of life in two pivotal phase III placebo-controlled studies.
  • Note that revefenacin, if FDA-approved, would be the first once daily, long-acting muscarinic antagonist (LAMA) indicated for patients with COPD.

TORONTO — An investigational long-acting drug for chronic obstructive pulmonary disease (COPD), delivered by nebulizer, improved patient quality of life in two pivotal studies, researchers said here.

In a pooled analysis of the placebo-controlled phase III trials 0126 and 0127, patients reported marked improvement on two scales, the St George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) with revefenacin treatment, according to James Donohue, MD, of the University of North Carolina in Chapel Hill, and colleagues.

On both scales, patients reported “clinically meaningful” responses to the drug in secondary analyses, Donohue reported at CHEST, the American College of Chest Physicians annual meeting.

If approved, revefenacin would be the first once daily, long-acting muscarinic antagonist (LAMA) indicated for patients with COPD, Donohue said. He told MedPage Today it would be an important addition to the armamentarium of therapy for patients who require a nebulized treatment.

“What’s unique is that it’s in a nebulizer and it’s 24 hours,” he noted.

The results of the study are “important,” commented CHEST session co-moderator Arthur Gelb, MD, of the University of California Los Angeles. “Hopefully, [the drug] will reach clinical utilization soon.”

Donohue said the FDA is expected to make a decision soon, although it’s unclear which of two tested doses will get the nod.

Gelb told MedPage Today that one advantage of revefenacin is that it would be the “only LAMA that would be inline,” which would make it more economical to use for patients admitted to hospital.

The two studies were identical, with 1,229 patients randomly assigned on a 1:1:1 basis to placebo, 88 μg of revefenacin, or 175 μg of the drug. The primary endpoints were efficacy and safety over a 12-week period, he said.

Patients in the study were well balanced across the arms in terms of demographics. About half were current smokers and a similar proportion reported a modified Medical Research Council dyspnea score of at least 2.

Patients had moderate to severe COPD with a high risk of exacerbations, with most having GOLD system scores of 2 or 3 on numerical scoring or B and C on the alphabetical scale. Participants were “very typical” of patients in a COPD trial, Donohue said.

He noted that investigators have earlier reported that the drug had beneficial effects on breathing, with “robust” and statistically significant improvements, compared with placebo, in one-second forced expiratory volume (FEV1).

Also, the rate of adverse events in the three arms was similar, with “no really clear-cut effect in [adverse events] of the higher dose.”

Aside from efficacy and safety, key secondary analyses included patient reported outcomes, at baseline and on day 85 of treatment, on the SGRQ and CAT. The researchers recorded total scores and proportion of responders.

The analysis showed that in the 0126 study, total SGRQ scores were similar for both doses, with a significant drop of about 4 points from baseline, compared with a slight but non-significant increase among those on placebo. The greatest improvement was seen on the symptom subscale.

In the 0127 study, outcomes were much the same, but a greater than expected placebo response meant that the change with the lower dose of revefenacin did not reach statistical significance.

Over both studies, patients taking the drug were about 50% more likely to reach the 4-point improvement threshold than those on placebo, with an odds ratio of 1.56 for 88-μg dose and an OR 1.53 for the 175-μg dose.

In study 0126, both doses significantly improved total scores on the CAT, but again owing to the unexpected placebo response, only the 175-μg dose had significantly better scores in the 0127 study.

In 0126, both doses were significantly associated with a clinically meaningful CAT response, but in 0127, only the higher dose was significantly better than placebo.

Taken together, the studies demonstrated “improvements in the health status” of people using revefenacin, according to Donohue.

The study was supported by Theravance Biopharma. Several co-authors are company employees.

Donohue disclosed relevant relationships with Theravance Biopharma, Mylan, and Sunovion.

Gelb disclosed no relevant relationships with industry.

2017-10-30T09:30:00-0400

Tagged with:

About author

Related Articles