Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate
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|ClinicalTrials.gov Identifier: NCT02649478|
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Fluticasone / Salmeterol Drug: Placebo Drug: Advair Diskus 100/50||Not Applicable|
The primary objective of this study is to evaluate the clinical bioequivalence of generic fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder (test) to Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma.
The secondary objectives of the study are:
- To demonstrate statistical superiority of generic fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder to placebo.
- To demonstrate statistical superiority of Advair 100/50 to placebo.
- To investigate the safety and tolerability of fluticasone propionate 100 µg and salmeterol xinafoate 50 µg inhalation powder compared with Advair 100/50 in the target population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder Compared With Advair Diskus® 100/50 in Subjects With Asthma|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Fluticasone / Salmeterol
fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura lever operated multidose inhaler ("LOMI") inhaler device twice a day by inhalation throughout the study
Drug: Fluticasone / Salmeterol
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura LOMI inhaler device
Active Comparator: Advair Diskus 100/50
Advair Diskus (fluticasone propionate and salmeterol xinafoate) twice a day by inhalation throughout the study
Drug: Advair Diskus 100/50
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)
Placebo Comparator: placebo inhaler
placebo inhaled powder twice a day by inhalation throughout the study
- Baseline-adjusted area under the serial FEV1-time curve from time 0 to 12 hours on the first day of the Treatment Period [ Time Frame: 0-12 hours after dosing on Day 1 ]
- Baseline-adjusted, pre-dose FEV1 on the last day of the Treatment Period [ Time Frame: 30 Days ]
- Adverse Events [ Time Frame: From Visit 1 (Day -28) until 30 days after the last dose of study drug ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649478
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