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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)

Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI)  (PT003, GFF MDI)

Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT ID

Patient Level Data

Therapeutic Area

Budesonide, Glycopyrronium, and Formoterol Fumarate

PT010008-01_Protocol_Version_2.0_REDACTED.pdf

Research Site

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

The Safety Population included only subjects who signed ICF for Study PT010008  and received any amount of study drug (other than Symbicort).

Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.

BMD Population was defined as all evaluable subjects in the Safety Population who had a
baseline BMD assessment and at least 1 on-treatment BMD assessment. Subjects were
analyzed according to actual study drug received.

Percent Change from Baseline in BMD of the Lumbar Spine

Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52.  P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule).  A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within  0.5 is an acceptable variation margin.

Ophthalmologic Population was defined as all evaluable subjects in the Safety Population
who had a baseline ophthalmologic assessment and at least 1 on-treatment ophthalmologic
assessment. Subjects were analyzed according to actual study drug received.

Change from baseline in the LOCS III (P) score at Week 52

Overall Study

Subjects were randomized in a 2:2:1 scheme (BGF MDI:GFF MDI:BFF MDI).

Arms	Assigned Interventions
Experimental: BGF MDI (PT010) 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)	Drug: BGF MDI 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Other Name: BGF MDI
Experimental: GFF MDI (PT003) 14.4/9.6 μg Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)	Drug: GFF MDI 14.4/9.6 μg Glycopyrronium and Formoterol Fumarate Other Name: GFF MDI
Experimental: BFF MDI (PT009) 320/9.6 μg Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)	Drug: BFF MDI 320/9.6 μg Budesonide and Formoterol Fumarate Other Name: BFF MDI

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

PT010008-01_Protocol_Version_2.0_REDACTED.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator