Q. Can non-aerosol equivalent inhalers be prescribed?

A. Yes if they have the same dose and active ingredients within them.

Q. Can Luforbec be used as an equivalent to Fostair/Symbicort?

A. Yes, as above, generic equivalents are acceptable if they have the same dose and active ingredients within them. Below are listed the most common equivalents and their accepted dosages.

Fostair 100/6

Symbicort 100/6

Luforbec 100/6

Fobumix 80/4.5

Q. What is the maximum number of puffs for the combined inhalers?

A. 12 puffs in any 24-hour period as per the SmPC guidelines (Symbicort).

     8 puffs in any 24-hour period as per the SmPC guidelines (Fostair).

Q. What advice do we give patients regarding the use of their 'as required' combined inhaler during an asthma exacerbation?

A. Patients are usually advised to wait for 10 – 15 minutes and then repeat inhalation if still symptomatic, as with salbutamol. However, there is no time limit between puffs during an exacerbation. Patients should be advised to call for emergency help if there is no improvement exactly as they would if using standard salbutamol reliever.

Q. Is RELIEF using the MART or SMART regimen for the combined inhaler?

A. No, the combined inhaler is being used as an ‘as required’ reliever in the RELIEF trial, much in the same way as salbutamol is used. The combined inhaler is not intended as a maintenance inhaler for the RELIEF trial. However, if the patients’ low dose inhaled corticosteroid treatment is changed during the trial for any reason, for example because their asthma becomes more severe, please note this on the trial database. The patient can still be followed up in accordance with the trial schedule if they are willing to do so. Patient non-compliance is not considered a protocol deviation in the RELIEF trial.

Q: Some patients meet the mild asthma criteria and have prescriptions for an inhaled corticosteroid (brown inhaler) and Salbutamol, but have not taken either for a significant time since prescribed, can they be invited, and the criteria explained to them if they are interested in participating?

A: It is suggested that any patient prescribed an ICS with or without Salbutamol can enter the RELIEF trial even if it is clear they do not always use it or collect their prescription. We know that patient non-compliance with treatment is a common problem, and this is part of the reason we are doing the study.

However, if the patient has stopped using their ICS inhaler completely and is only using their Salbutamol inhaler, they would need to restart ICS treatment for at least 4 weeks prior to entering the trial. Potential participants would need to agree to use the ICS inhaler for the specified period of time, alongside their salbutamol reliever, in order to meet the inclusion criteria.

Q: What about cases where a patient has not collected a repeat prescription for one or both of their inhalers for months at a time? Can these patients still be included in the RELIEF trial?

A: If a patient has not collected either their ICS or Salbutamol inhaler for a few months, they may have seasonal asthma and can be entered. If, however , the diagnosis is not clear please do not enter them.

Q. When a patient with a diagnosis of mild asthma is only on Salbutamol, can they be entered into the RELIEF trial?

A. Patients that use ICS inhalers intermittently or seasonally are eligible. However, if they have stopped using their ICS inhaler completely and only use a Salbutamol inhaler, they need to restart ICS to meet the inclusion criteria. They can then participate in the RELIEF trial after at least 4 weeks of ICS use.

Q. Can my practice participate in the RELIEF trial if we are already participating in another asthma trial?

A. Your practice can still participate in RELIEF, but patients already participating in other asthma trials should not be randomised into RELIEF.

Q: Can a patient be including in the RELIEF trial if they are taking systemic steroids for another condition?

A: No please do not include patients taking systemic steroids for asthma or other conditions.

Q: Can pregnant patients be included in RELIEF?

A: While there are no safety issues, patients who are pregnant or intending to become pregnant should not be included in the RELIEF trial. If a participant becomes pregnant during the trial, and is in either arm of the trial, she should be withdrawn from the trial.

Q: What are the inclusion criteria?

A: To be included in the study, patients must have a clinical diagnosis of mild asthma and must be treated with low dose ICS (brown inhaler for maintenance) and be prescribed 11 or less canisters of Salbutamol (blue inhaler for relieving symptoms) in the last 12 months Please always refer to the Protocol and/or SIV training slides for full eligibility criteria.

Q: What will be prescribed for patients in the usual care arm?

A: Patients randomised to the usual care arm will remain on daily low dose ICS for maintenance and Salbutamol for symptom relief.

Q: What will be prescribed for patients in the treatment/intervention arm?

A: Patients randomised to the treatment arm will be prescribed daily low dose ICS (e.g., Clenil) for maintenance and combined ICS/Formoterol for symptom relief instead of their usual salbutamol.