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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)

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ClinicalTrials.gov Identifier: NCT02766608
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disorder Drug: BFF MDI 320/9.6 μg Drug: BFF MDI 160/9.6 μg Drug: FF MDI 9.6 μg Drug: BD MDI 320 μg Drug: Symbicort® TBH 400/12 μg BID Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
Actual Study Start Date : May 31, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Arm Intervention/treatment
Experimental: BFF MDI 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI 320/9.6 μg
Blinded Treatment
Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol

Experimental: BFF MDI 160/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BFF MDI 160/9.6 μg
Blinded Treatment
Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol

Experimental: FF MDI 9.6 μg
Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID
Drug: FF MDI 9.6 μg
Blinded Treatment
Other Name: Formoterol Fumarate Inhalation Aerosol

Experimental: BD MDI 320 μg
Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Drug: BD MDI 320 μg
Blinded Treatment
Other Name: Budesonide Inhalation Aerosol

Symbicort® TBH 400/12 μg
Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID
Drug: Symbicort® TBH 400/12 μg BID
Open Label
Other Name: Symbicort® Turbuhaler




Primary Outcome Measures :
  1. Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI) [ Time Frame: at Week 24 ]
    Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)

  2. Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI) [ Time Frame: at Week 24 ]
    Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.


Secondary Outcome Measures :
  1. Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). [ Time Frame: over 24 Weeks (timepoints of 4, 12 & 20 weeks) ]
    Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).

  2. Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24 [ Time Frame: at Week 24 ]
    The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.

  3. Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI) [ Time Frame: at Week 24 ]
    Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)

  4. Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI) [ Time Frame: at Week 24 ]
    Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)

  5. Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI) [ Time Frame: over 24 Weeks ]
    Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)

  6. FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination [ Time Frame: Day 1 - 5 Minutes ]
    Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.

  7. FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination [ Time Frame: Day 1 - 15 Minutes ]
    Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.

  8. FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination [ Time Frame: Day 1 - 30 Minutes ]
    Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.

  9. FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination [ Time Frame: Day 1 - 1 Hour ]
    Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.

  10. FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination [ Time Frame: Day 1 - 2 Hours ]
    Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.

  11. FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination [ Time Frame: Day 1 - 4 Hours ]
    Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.


Other Outcome Measures:
  1. Substudy: 12-hour PFT Endpoint FEV1 AUC0-12 [ Time Frame: at Week 12 ]
    Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766608


  Show 260 Study Locations
Sponsors and Collaborators
Pearl Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Pearl Therapeutics, Inc.:
Study Protocol  [PDF] October 24, 2017
Statistical Analysis Plan  [PDF] December 11, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02766608     History of Changes
Other Study ID Numbers: PT009002
First Posted: May 10, 2016    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: July 2019
Keywords provided by Pearl Therapeutics, Inc.:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Budesonide
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action