you attend the first clinic appointment after joining the study. during this visit you receive information about the study procedures, sign the consent form, and undergo initial measurements of lung function called fev1.

you are assigned a random treatment order. the study uses a double‑dummy design, meaning you will receive both an active inhaler and a matching placebo inhaler, but you will not know which contains the study medication.

you begin the first 12‑week treatment period according to the randomised order.

if you are assigned to the qvm149 arm, you use the inhaler once each morning. each dose contains 150 µg mometasone furoate, 50 µg glycopyrronium bromide and 160 µg indacaterol acetate. the inhaler is a dry‑powder capsule that you inhale through the mouth.

if you are assigned to the comparator arm, you use the inhaler twice daily, morning and evening. each inhalation delivers 50 µg fluticasone propionate and 500 µg salmeterol. the inhaler is a pre‑dispensed powder.

in both arms you also use a matching placebo inhaler to keep the dosing schedule identical. the placebo contains no active drug.

you continue your regular asthma controller medication, which is the seretide accuhaler. this inhaler provides fluticasone propionate and salmeterol and is taken as prescribed by your usual routine.

for sudden breathing difficulties you keep the ventolin rescue inhaler, which contains 800 µg salbutamol per dose. you use it only when you experience symptoms such as wheezing or shortness of breath.

each day you follow the dosing schedule assigned to you:

• for qvm149 – one inhalation in the morning.
• for the comparator – one inhalation in the morning and one in the evening.
• the matching placebo inhaler is taken at the opposite times to keep the total number of inhalations the same.

you record any use of the rescue inhaler in a diary provided by the study team.

you attend scheduled clinic visits at regular intervals (typically every four weeks) to allow the study staff to measure lung function, collect safety information, and review your diary.

during these visits you may complete questionnaires such as the asthma control questionnaire (acq‑5) and the pediatric asthma quality of life questionnaire (paqlq).

after 12 weeks you return to the clinic for a final assessment of the first period. the results of lung function, questionnaire scores, and rescue medication use are recorded.

a short wash‑out period is then observed, during which you stop the study inhalers but continue your regular background medication. this allows any effects of the first treatment to clear before starting the next period.

you begin the second 12‑week treatment period, receiving the medication that was not given in the first period.

the dosing schedule mirrors the first period: if you previously used qvm149, you now use the comparator inhaler twice daily with matching placebo once daily, and vice versa.

you continue the same daily inhalation routine as described for the first period, including use of the rescue inhaler as needed.

clinic visits are repeated at the same intervals to assess lung function, safety parameters, and questionnaire responses.

at the end of the second 12‑week period you attend a final clinic visit. all study assessments are performed, including lung function measurement, safety lab tests, and collection of your rescue‑inhaler diary.

after this visit the study medication is stopped and you return to your usual asthma management plan.