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)

P

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

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial documents
2

Trial contacts and locations

260

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Data sourced from clinicaltrials.gov

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