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Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04609878
Collaborator
(none)
2,200
Enrollment
424
Locations
4
Arms
37
Anticipated Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Condition or Disease Intervention/Treatment Phase
  • Drug: BGF MDI 320/28.8/9.6 μg
  • Drug: BGF MDI 320/14.4/9.6 μg
  • Drug: BFF MDI 320/9.6 μg
  • Drug: BFF pMDI 320/9 μg
 Phase 3

Detailed Description

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
Actual Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Jan 16, 2024
Anticipated Study Completion Date :
Jan 16, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg

BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Drug: BGF MDI 320/28.8/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Other Names:
  • BGF

    		•
    Experimental: BGF MDI 320/14.4/9.6 μg

    BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

    Drug: BGF MDI 320/14.4/9.6 μg
    Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
    Other Names:
  • BGF

    		•
    Active Comparator: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg

    BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)

    Drug: BFF MDI 320/9.6 μg
    Budesonide and formoterol fumarate metered dose inhaler
    Other Names:
  • BFF

    		•
    Active Comparator: Symbicort®

    Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg

    Drug: BFF pMDI 320/9 μg
    Budesonide/formoterol fumarate pressurized metered dose inhaler
    Other Names:
  • Symbicort®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 [24 Weeks]

      Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24

    2. Rate of severe asthma exacerbations [Up to 52 weeks]

      Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations

    Secondary Outcome Measures

    1. Change from baseline in morning pre-dose trough FEV1 at Week 24 [24 Weeks]

      Change from baseline in morning pre-dose trough FEV1 at Week 24

    2. Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24 [24 weeks]

      Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008

    3. Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 [24 Weeks]

      Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008

    4. Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24 [24 weeks]

      Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008

    5. Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24 [24 Weeks]

      Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24

    6. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 [Day 1]

      Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1

    7. Time to first severe asthma exacerbation [Up to 52 Weeks]

      Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation

    8. Rate of moderate/severe asthma exacerbations [Up to 52 Weeks]

      Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations

    9. Time to first moderate/severe asthma exacerbation [Up to 52 Weeks]

      Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first moderate/severe asthma exacerbation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.

    2. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.

    3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.

    4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).

    5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)

    • Participants > and/or = 18 years of age: < 80%

    • Participants 12 to <18 years of age: < 90%

    1. FEV1 post-albuterol at V2 or V3 (if repeat needed).

    • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.

    • Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.

    • Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1.

    1. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.

    2. Demonstrate acceptable MDI/pMDI administration technique.

    3. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).

    4. eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).

    5. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.

    Exclusion Criteria:
    1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

    2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

    2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.

    1. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

    2. Current evidence of Chronic Obstructive Pulmonary Disease (COPD).

    5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

    5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

    5c. Depot corticosteroid use for any reason within 12 months of V1.

    1. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.

    2. Use of oral b2-agonist within 3 months of V1.

    3. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

    4. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

    5. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

    6. Hospitalization for asthma within 2 months of Visit 1.

    7. Known history of drug or alcohol abuse within 12 months of Visit 1.

    8. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

    9. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

    10. Participation in another clinical study with an Investigational Product.

    11. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

    12. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

    13. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

    Please refer to the study protocol for the complete inclusion and exclusion criteria list.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States 35243
    2 Research Site Huntsville Alabama United States 35802
    3 Research Site Saraland Alabama United States 36571
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    370 Research Site Szczecin Poland 70-111
    371 Research Site Tarnów Poland 33-100
    372 Research Site Wroclaw Poland 54-239
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    374 Research Site Caguas Puerto Rico 00726
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    378 Research Site Brasov Romania 500051
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    381 Research Site Bucharest Romania 50159
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    385 Research Site L'Hospitalet de Llobregat Spain 08907
    386 Research Site Madrid Spain 28007
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    390 Research Site Pozuelo de Alarcón Spain 28223
    391 Research Site Santander Spain 39008
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    394 Research Site Zaragoza Spain 50009
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    396 Research Site Changhua Taiwan 50006
    397 Research Site Kaohsiung City Taiwan 80756
    398 Research Site Kaohsiung Taiwan 82445
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    400 Research Site New Taipei Taiwan 23561
    401 Research Site Taichung Taiwan 40447
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    403 Research Site Tainan Taiwan 704
    404 Research Site Taipei City Taiwan 110
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    408 Research Site Bang Kra So Thailand 11000
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    414 Research Site Khon Kaen Thailand 40002
    415 Research Site Mae Rim Thailand 50180
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    418 Research Site Ha Noi Vietnam 100000
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    420 Research Site Ho Chi Minh City Vietnam 70000
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    423 Research Site Hochiminh Vietnam 700000
    424 Research Site Hochiminh Vietnam

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Andrew Menzies-Gow, MD, Royal Brompton Hospital, United Kingdom

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04609878
    Other Study ID Numbers:
    • D5982C00007
    • 2020-001520-34
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma
    Budesonide, Formoterol Fumarate Drug Combination

    Study Results

    No Results Posted as of Aug 24, 2022