Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (telos)

Pearl Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disorder

Treatments: Drug: FF MDI 9.6 μg; Drug: BFF MDI 160/9.6 μg; Drug: Symbicort® TBH 400/12 μg BID; Drug: BFF MDI 320/9.6 μg; Drug: BD MDI 320 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02766608

PT009002

Details and patient eligibility

About

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

Full description

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.

Enrollment: 2,389 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Give their signed written informed consent to participate
2. Are at least 40 years of age and no older than 80 years
3. COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

Exclusion criteria

1. Current diagnosis of asthma,
2. COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
4. Long-term-oxygen therapy (≥ 12 hours a day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,389 participants in 5 patient groups

BFF MDI 320/9.6 μg

Experimental group

Description:

Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: BFF MDI 320/9.6 μg

BFF MDI 160/9.6 μg

Experimental group

Description:

Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: BFF MDI 160/9.6 μg

FF MDI 9.6 μg

Experimental group

Description:

Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: FF MDI 9.6 μg

BD MDI 320 μg

Experimental group

Description:

Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: BD MDI 320 μg

Symbicort® TBH 400/12 μg

Other group

Description:

Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID

Treatment:

Drug: Symbicort® TBH 400/12 μg BID