A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics

NCT ID: NCT02126839

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-02-28

Brief Summary

The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo MDPI QID

Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo delivered via a multidose dry powder inhaler (MDPI).

ProAir HFA inhaler

Intervention Type: DRUG

Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.

Albuterol MDPI 180 mcg QID

Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.

Group Type: EXPERIMENTAL

Albuterol MDPI

Intervention Type: DRUG

90 mcg/actuation of the multidose dry powder inhaler (MDPI).

ProAir HFA inhaler

Intervention Type: DRUG

Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.

Interventions

Albuterol MDPI

90 mcg/actuation of the multidose dry powder inhaler (MDPI).

Intervention Type: DRUG

Placebo

Matching Placebo delivered via a multidose dry powder inhaler (MDPI).

Intervention Type: DRUG

ProAir HFA inhaler

Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.

Intervention Type: DRUG

Other Intervention Names

Spiromax®; albuterol

Eligibility Criteria

Inclusion Criteria

1. Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study related procedure

2. Male or premenarchal female 4-11 years of age, inclusive, as of the screening visit (SV)

3. Has a documented physician diagnosis of asthma per the EPR-3 Guidelines of a minimum of 6 months duration that has been stable for at least 4 weeks prior to the SV

4. Has the ability to perform spirometry reproducibly consistent with ATS guidelines and protocol-specific guidelines

5. Has FEV1 50-95% predicted for age, height and gender at the SV following a minimum 6-hour period without β2-agonist use. (Note: Predicted values of 49.50-49.99% may be rounded up to 50% and values of 95.01-95.49% may be rounded down to 95%.)

6. Demonstrated reversible bronchoconstriction as verified by a 15% or greater increase in baseline FEV1 within 30 minutes following inhalation of 180 mcg of albuterol. (Note: Reversibility values of 14.50-14.99% may be rounded up to 15%.)

7. Is maintained on low-dose inhaled corticosteroids (ICS, less than or equal to 200 mcg of fluticasone propionate per day or equivalent), leukotriene modifiers (LTM), or inhaled cromones, and/or on short-acting β2-agonists (SABA); as needed SABA alone is acceptable. The ICS, LTM, and cromone doses must have been stable for at least 4 weeks prior to the SV and should be maintained for the duration of the study

8. Can self-perform peak expiratory flow rate (PEF) measurements with a handheld peak flow meter

9. Can tolerate the withdrawal of applicable medications for qualification at screening

10. Otherwise in general good health, defined as free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial, and with a clinically acceptable 6-month medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs

11. Parents consenting are capable of understanding the requirements, risks and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and being compliant with all study requirements (eg, visits, record-keeping)

12. The patient is able to correctly use the MDPI device, either alone or with assistance by a parent/guardian.

Exclusion Criteria

1. Known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (eg, lactose, ethanol)

2. Participation (receiving study medication) in any investigational drug trial within the 30 days preceding the SV or planned participation in another investigational drug trial at any time during this trial

3. History of severe milk protein allergy

4. History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza) that has not resolved within 4 weeks preceding the SV

5. Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A patient must not have had any hospitalization for asthma within 6 months prior to the SV.

6. Initiation of immunotherapy during the study period or dose escalation during the study period. Patients being treated with immunotherapy prior to the SV must be using a stable (maintenance) dose (90 days or more) to be considered for inclusion.

7. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures

8. Use of any prohibited concomitant medications within the washout prescribed per protocol prior to study visits

9. Use of any medication for asthma or allergic rhinitis that is prohibited per the protocol as described in the protocol

10. The dosage of any required LTM, ICS, or inhaled cromones, has not been stable for at least 4 weeks. Intranasal corticosteroid and/or cromones have not been stable for at least two weeks prior to the SV. Allowed corticosteroid, LTM, and cromone asthma and allergy medications should be continued at the same doses during the conduct of the study.

11. Presence of any non-asthmatic acute or chronic condition, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis, clinically significant cardiovascular disease (including but not limited to cardiac arrhythmias and uncontrolled hypertension), clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes mellitus, hyperthyroidism, convulsive disorder, and malignancy other than basal cell carcinoma. Significant is defined as any condition that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the safety or efficacy analyses

12. Any other medical or psychological condition that in the investigator's opinion should preclude study enrollment

13. Previous participation (received MDPI study medication) in an Albuterol MDPI study

14. Study participation by clinical investigator site employees and/or their immediate relatives

15. Study participation by related or non-related individuals living in the same household, ie, only one subject per household may participate in the study at the same time.

16. Require continuous treatment with β-blockers, MAO inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids

17. Treated with oral or injectable corticosteroids within the 6 weeks prior to SV

18. Hospitalization for acute asthma exacerbation >2 times in 12 months prior to screening and/or received emergency room treatment other than nebulized albuterol or been hospitalized for asthma exacerbations within 6 months prior to SV

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 12496

Birmingham, Alabama, United States

Teva Investigational Site 12500

Mobile, Alabama, United States

Teva Investigational Site 12481

Little Rock, Alaska, United States

Teva Investigational Site 12515

Anaheim, California, United States

Teva Investigational Site 12505

Costa Mesa, California, United States

Teva Investigational Site 12476

Huntington Beach, California, United States

Teva Investigational Site 12519

Los Angeles, California, United States

Teva Investigational Site 12484

Mission Viejo, California, United States

Teva Investigational Site 12510

Riverside, California, United States

Teva Investigational Site 12483

Rolling Hills Estates, California, United States

Teva Investigational Site 12511

Sacramento, California, United States

Teva Investigational Site 12485

Stockton, California, United States

Teva Investigational Site 12512

Centennial, Colorado, United States

Teva Investigational Site 12522

Gainesville, Florida, United States

Teva Investigational Site 12535

Hollywood, Florida, United States

Teva Investigational Site 12526

Miami, Florida, United States

Teva Investigational Site 12516

Orlando, Florida, United States

Teva Investigational Site 12517

Tamarac, Florida, United States

Teva Investigational Site 12527

Vero Beach, Florida, United States

Teva Investigational Site 12513

Winter Park, Florida, United States

Teva Investigational Site 12486

Gainesville, Georgia, United States

Teva Investigational Site 12497

Lawrenceville, Georgia, United States

Teva Investigational Site 12480

Savannah, Georgia, United States

Teva Investigational Site 12508

Shiloh, Illinois, United States

Teva Investigational Site 12518

Iowa City, Iowa, United States

Teva Investigational Site 12523

Covington, Louisiana, United States

Teva Investigational Site 12495

Warrensburg, Missouri, United States

Teva Investigational Site 12509

Northfield, New Jersey, United States

Teva Investigational Site 12524

Brooklyn, New York, United States

Teva Investigational Site 12473

Raleigh, North Carolina, United States

Teva Investigational Site 12477

Cincinnati, Ohio, United States

Teva Investigational Site 12525

Cleveland, Ohio, United States

Teva Investigational Site 12502

Middleburg Heights, Ohio, United States

Teva Investigational Site 12478

Oklahoma City, Oklahoma, United States

Teva Investigational Site 12487

Oklahoma City, Oklahoma, United States

Teva Investigational Site 12506

Oklahoma City, Oklahoma, United States

Teva Investigational Site 12492

Tulsa, Oklahoma, United States

Teva Investigational Site 12507

Gresham, Oregon, United States

Teva Investigational Site 12501

Normal Square, Pennsylvania, United States

Teva Investigational Site 12493

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 12488

Upland, Pennsylvania, United States

Teva Investigational Site 12514

Greenville, South Carolina, United States

Teva Investigational Site 12474

Orangeburg, South Carolina, United States

Teva Investigational Site 12479

Spartanburg, South Carolina, United States

Teva Investigational Site 12489

Boerne, Texas, United States

Teva Investigational Site 12475

Waco, Texas, United States

Teva Investigational Site 12491

Burke, Virginia, United States

Teva Investigational Site 12504

Charlottesville, Virginia, United States

Teva Investigational Site 12482

Richmond, Virginia, United States

Teva Investigational Site 12498

Richmond, Virginia, United States

Teva Investigational Site 12490

Spokane, Washington, United States

Teva Investigational Site 12533

Papillion, NE, Thailand

Countries

United States; Thailand

References

Ratnayake A, Taveras H, Iverson H, Shore P. Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma. Allergy Asthma Proc. 2016 Sep;37(5):370-5. doi: 10.2500/aap.2016.37.3985. Epub 2016 Aug 12.

Reference Type: DERIVED

PMID: 27523719 (View on PubMed)

Other Identifiers

ABS-AS-303

Identifier Type: -

Identifier Source: org_study_id