Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Tiotropium inhalation powder; Drug: PT001; Drug: PT003; Drug: PT005

Study type: Interventional

Funder types: Industry

Identifiers

NCT01587079

PT003005

Details and patient eligibility

About

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Enrollment: 159 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Signed written informed consent
• 40 - 80 years of age
• Clinical history of COPD with airflow limitation that is not fully reversible
• Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
• Current/former smokers with at least a 10 pack-year history of cigarette smoking
• A measured post-bronchodilator FEV1/FVC ratio of < or = 0.70
• A measured post-bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
• Able to change COPD treatment as required by protocol

Key Exclusion Criteria:

• Women who are pregnant or lactating
• Primary diagnosis of asthma
• Alpha-1 antitrypsin deficiency as the cause of COPD
• Active pulmonary diseases
• Prior lung volume reduction surgery
• Abnormal chest X-ray not due to the presence of COPD
• Hospitalized due to poorly controlled COPD within 3 months of Screening
• Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
• Cancer that has not been in complete remission for at least 5 years
• Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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159 participants in 8 patient groups

PT003 (Dose 1)

Experimental group

Description:

PT003 MDI Dose 1

Treatment:

Drug: PT003

PT003 (Dose 2)

Experimental group

Description:

PT003 MDI Dose 2

Treatment:

Drug: PT003

PT003 (Dose 3)

Experimental group

Description:

PT003 MDI Dose 3

Treatment:

Drug: PT003

PT003 (Dose 4)

Experimental group

Description:

PT003 MDI Dose 4

Treatment:

Drug: PT003

PT003 (Dose 5)

Experimental group

Description:

PT003 MDI Dose 5

Treatment:

Drug: PT003

PT001

Experimental group

Description:

PT001 MDI

Treatment:

Drug: PT001

PT005

Experimental group

Description:

PT005 MDI

Treatment:

Drug: PT005

Spiriva® Handihaler®

Active Comparator group

Description:

Tiotropium Bromide

Treatment:

Drug: Tiotropium inhalation powder