Researchers, lead by Respiratory Research’s Professor David Price, completed a two-year long pragmatic trial into the “real-world effectiveness” of an orally administered leukotriene-receptor antagonist (LTRA).
LTRA was compared with either an inhaled glucocorticoid for first-line asthma-controller therapy or a long-acting beta2-agonist (LABA) as add-on therapy in patients already receiving inhaled glucocorticoid therapy.
And though the team found the LTRA was only equally effective as inhaled steroids, they concluded the pill was easier to administer and more patients preferred it.
Price now believes the medication could take over from the traditional inhaled glucocorticoid therapy in up to 50 per cent of patients.
He told In-PharmaTechnologist: “LTRA is a different agent that is orally active and well tolerated. The inhaled drugs are used in inhalers as steroids and beta agonists are not safe orally.
“We know that inhalers are a problem. People have poor inhaler techniques, people don’t like inhaling, people say it is trying and embarrassing.
“Equally some people don’t want to take a pill because they don’t like the idea of it being in their health system.
“We didn’t look at the reasons for different adherence within the two trials, but through the efficacious study what we do know is that many of the classical inhaled steroid patients do not do well.
“In effect, this could mean leukotriene antagonists being used as first line therapy for milder community asthma and inhalers used only when that fails to give incomplete control. It’s possible this could account for 50 per cent of patients.”
Within the study’s conclusion the investigators admit the possible limitations of the largely unchartered pragmatic study – in which crossovers between treatment groups were entirely plausible and where there was a lack of a placebo group – leaving most questioning how the team can validate research of its kind.
And in a paper questioning the general legitimacy of pragmatic trials for Evidence-Based Medicine for Primary Care and International Medicine (EBM) Paul J Karanicolas et al wrote: “The current conceptualisation of pragmatic trials sometimes serves the needs of only a small proportion of healthcare decision makers.”
But Price insisted a real-life trial was crucial for plugging gaps left in previous respiratory disease studies which he accuses of cherry picking their test subjects.
Here candidates were between 12 and 80 years of age and had scored six or less in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), or one or more in the Asthma Control Questionnaire (ACQ).
However unlike many studies which have gone before it, these were the only criteria for patient recruitment.
Price said: “It was a pragmatic trial because it gave us the opportunity to do a real life but still randomized study.
“It was quite different to the classical double blinding study that most pharmaceutical companies are good at doing. We tried to broaden the study by using a wide range of Primary Care patients.
“When using the classical double blinded study they tend to skip the people in real life situations. No smokers, no mild lung conditions, no other conditions. We took a cross section of real-life sufferers.”
Whether the new treatment will have as big an impact on the respiratory drug delivery industry as Price says it will remains to be seen.
However as the project has already received backing from a host of pharmaceutical giants – including Aerocrine, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Mundipharma, Novartis, Nycomed, Pfizer, Teva, and ChiesiCompanies – LTRA’s future looks bright.