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NCT01110200COMPLETEDanonymous

A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of COPD Following Hospitalization

Sponsor

Source record

GlaxoSmithKline

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

ADVAIR DISKUS 250/50 mg BID, SEREVENT 50 mcg BID

Indication / condition

AI-normalized

Pulmonary Disease, Chronic Obstructive

Intervention

Source record

ADVAIR DISKUS 250/50 mg BID, SEREVENT 50 mcg BID

Source & freshness

Source record

NCT ID

NCT01110200

Original source

ClinicalTrials.gov

Source last updated

Nov 08, 2017

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01110200

Title

A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of COPD Following Hospitalization

Sponsor

GlaxoSmithKline

Status

COMPLETED

Phase

PHASE4

Condition raw

Pulmonary Disease, Chronic Obstructive

Condition normalized

Pulmonary Disease, Chronic Obstructive

Modality raw

small molecule

Modality normalized

small molecule

Target raw

ADVAIR DISKUS 250/50 mg BID, SEREVENT 50 mcg BID

Target normalized

ADVAIR DISKUS 250/50 mg BID, SEREVENT 50 mcg BID

Interventions

ADVAIR DISKUS 250/50 mg BID, SEREVENT 50 mcg BID

Public preview

Source record

This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted in the United States. The purpose of the study is to evaluate the rate of exacerbations of chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The study population will include patients hospitalized for an acute exacerbation of COPD. The target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency room visit or physician's office visit for an exacerbation of COPD requiring treatment with oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination). Related efficacy endpoints include, time to first exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16) and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS); and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT). Albuterol will be supplied to study subjects for use as-needed throughout the study. Safety will be assessed by monitoring of adverse events.

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