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 |
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Recruitment Status :
Completed
First Posted : May 10, 2016
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
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Sponsor:
Pearl Therapeutics, Inc.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: BFF MDI 320/9.6 μg
Blinded Treatment
Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol |
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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
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Drug: BFF MDI 160/9.6 μg
Blinded Treatment
Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol |
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Experimental: FF MDI 9.6 μg
Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID
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Drug: FF MDI 9.6 μg
Blinded Treatment
Other Name: Formoterol Fumarate Inhalation Aerosol |
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Experimental: BD MDI 320 μg
Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
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Drug: BD MDI 320 μg
Blinded Treatment
Other Name: Budesonide Inhalation Aerosol |
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Symbicort® TBH 400/12 μg
Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID
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Drug: Symbicort® TBH 400/12 μg BID
Open Label
Other Name: Symbicort® Turbuhaler |
Primary Outcome Measures :
- 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)
- 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 :
- 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).
- 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.
- 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)
- 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)
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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:
- 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).
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
Locations
Show 260 study locations
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Study Documents (Full-Text)
Documents provided by Pearl Therapeutics, Inc.:
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):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pearl Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02766608 |
| 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.:
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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 |