Study: NCT02139644

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FS MDPI
Description: FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FS MDPI
Description: FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fp MDPI
Description: Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fp MDPI
Description: Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo MDPI
Description: Placebo administered via a multidose dry powder inhaler (MDPI) one puff in the morning and one puff in the evening for 12 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: albuterol/salbutamol
Description: A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: albuterol/salbutamol
Description: A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: albuterol/salbutamol
Description: A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: albuterol/salbutamol
Description: A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).