Study: NCT02141854

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FS MDPI
Description: FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate 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 fluticasone propionate/salmeterol MDPI 200/12.5 mcg or fluticasone propionate/salmeterol MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg.~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 and salmeterol xinafoate 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 fluticasone propionate/salmeterol MDPI 200/12.5 mcg or fluticasone propionate/salmeterol MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 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 (Fp) 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 200 mcg or 100 mcg of Fp one inhalation twice a day for a total daily dose of 400 mcg or 200 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 (Fp) 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 200 mcg or 100 mcg of Fp one inhalation twice a day for a total daily dose of 400 mcg or 200 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: The placebo multidose dry powder inhaler (MDPI) was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart). Patients were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albuterol/salmeterol HFA MDI
Description: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albuterol/salmeterol HFA MDI
Description: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albuterol/salmeterol HFA MDI
Description: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albuterol/salmeterol HFA MDI
Description: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Albuterol/salmeterol HFA MDI
Description: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.