Asthma is a major public health problem in most countries. Strategies to better control this disease must include predisposing factors. One of these factors is smoking and a significant proportion of asthmatics are smokers. Despite the logical expectation that people with asthma would avoid exposure to cigarette smoke, studies suggest that smoking behaviour is prevalent among asthmatics at a rate similar or higher to that found in the general population.
Cigarette smoke triggers tightening of the lungs (bronchoconstriction) in asthmatic patients. Smoking asthmatics have more severe breathing problems, worse quality of life and a faster loss of breathing ability compared to non-smoking asthmatics. They are also more likely to have emergency room visits and are at a higher risk of dying following hospitalization for near-fatal asthma events.
Despite the importance of smoking as a factor in asthma, clinical trials studying new drugs for asthma generally exclude smokers.
We are interested in examining smoking asthma patients' response to specific classes of inhaler drugs called inhaled corticosteroids. We aim to determine if there are differences in response between smokers and non-smokers, which would identify an unmet need that could be addressed by new asthma medications.
The primary objective is to compare the time to treatment failure from first initiating inhaled corticosteroids (ICS) or fixed dose inhaled corticosteroids/long acting beta agonists (FD ICS/LABA) treatment in smoking asthmatics and matched non-smoking asthmatics. Treatment failure will be defined as increased treatment dose, prescription of additional maintenance therapy, episode of moderate or severe asthma exacerbation or excessive use of short acting beta agonists (SABA).
The secondary objectives are to: compare time to moderate or severe exacerbation between smoking and non-smoking asthmatics; compare annualized rate of moderate or severe exacerbations between smoking and non-smoking asthmatics; describe the asthma related and all-cause health care resource utilization (HCRU) of smoking compare to non-smoking asthmatics; describe SABA use among smoking and non-smoking asthmatics.
Primary: to compare the time to treatment failure from first initiating ICS or ICS/LABA treatment in smoking vs matched non-smoking asthmatic patients.
-Secondary: To compare the annualized rate of moderate/severe exacerbations post ICS or ICS/LABA initiation between smoking and non-smoking asthmatics;
-Secondary: To describe the SABA use in smoking and matched non-smoking asthmatics;
-Secondary: To compare the time to moderate/severe exacerbation between smoking and matched non-smoking asthmatics who initiated an ICS_containing treatment (ICS or ICS/LABA);
-Secondary: To describe the asthma related and all-cause Health Care Resource Utilization of smoking asthmatics and non-smoking asthmatics.
Emil Loefroth - Chief Investigator - NOVARTIS
Paul McGettigan - Corresponding Applicant - Novartis Ireland Limited
Abheenava Kumar - Collaborator - Novartis Pharma AG ( Switzerland )
Himanshu Pradhan - Collaborator - Novartis Pharma AG ( Switzerland )
Hui Cao - Collaborator - NOVARTIS
Jessica Marvel - Collaborator - Novartis Pharmaceuticals Corporation ( USA )
Martin McSharry - Collaborator - Optum
HES Accident and Emergency;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation