Description:

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

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  1. 6/18/17
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June 18, 2017

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Creative Commons BY-NC 3.0
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Screening - GSK Milveterol COPD 100527

Screening - GSK Milveterol COPD 100527

Inclusion/Exclusion criteria
Did the subject meet all entry criteria (i.e., All "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
Demography
dd.mm.yyyy
dd.mm.yyyy
Sex
Race
cm
kg
Duration of Asthma
Duration of Asthma
Vital Signs
dd.mm.yyyy
hh:mm
mmHg
mmHg
beats/min
12-Lead Electrocardiogram
dd.mm.yyyy
hh:mm
beats/min
msec
msec
msec
msec
ECG finding
Is the abnormality clinically significant?
FEV1 / Reversibility Testing
dd.mm.yyyy
Test
hh:mm
%
%
Is the pre-sambutamol FEV1 >60% of predicted?
Is there an increase in FEV 1 of ≥ 12% over baseline and an absolute change of ≥300ml within 30 minutes following 400µg salbutamol administration?
Is the post-salbutamol FEV1/FVC ratio ≥ 0.7?
Hematology Data
dd.mm.yyyy
hh:mm
Were there any clinically significant hematology abnormalities?
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Clinical Chemistry Data
dd.mm.yyyy
hh:mm
Were there any clinically significant clinical chemistry abnormalities?
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Urinalysis
dd.mm.yyyy
hh:mm
Were there any clinically significant urinalysis abnormalities?
Dip sticks: Protein
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Dip sticks: Blood
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Dip sticks: Ketones
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Dip sticks: Glucose
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Dip sticks: Bilirubin
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
Dip sticks: Leucocytes
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key:
lf clinically significant, record primary reason for the clinically significant abnormality in by using the following key: