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AsthmaPhase 3NCT02126839

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

A Phase 3 study testing Albuterol MDPI and ProAir HFA inhaler in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Asthma
What is being tested?
Albuterol MDPI and ProAir HFA inhaler
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
186 participants
Where
52 sitesin 2 countries
Study dates
May 2014to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study related procedure
  • Male or premenarchal female 4-11 years of age, inclusive, as of the screening visit (SV)
  • 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
  • Has the ability to perform spirometry reproducibly consistent with ATS guidelines and protocol-specific guidelines
  • 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%.)
  • 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%.)
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  • 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
  • Can self-perform peak expiratory flow rate (PEF) measurements with a handheld peak flow meter
  • Can tolerate the withdrawal of applicable medications for qualification at screening
  • 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
  • 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)
  • The patient is able to correctly use the MDPI device, either alone or with assistance by a parent/guardian.

Who cannot join

  • Known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (eg, lactose, ethanol)
  • 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
  • History of severe milk protein allergy
  • 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
  • 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.
  • 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.
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  • 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
  • Use of any prohibited concomitant medications within the washout prescribed per protocol prior to study visits
  • Use of any medication for asthma or allergic rhinitis that is prohibited per the protocol as described in the protocol
  • 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.
  • 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
  • Any other medical or psychological condition that in the investigator's opinion should preclude study enrollment
  • Previous participation (received MDPI study medication) in an Albuterol MDPI study
  • Study participation by clinical investigator site employees and/or their immediate relatives
  • 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.
  • Require continuous treatment with β-blockers, MAO inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
  • Treated with oral or injectable corticosteroids within the 6 weeks prior to SV
  • 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

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States51 sites

  • Teva Investigational Site 12515

    Anaheim, California

  • Teva Investigational Site 12496

    Birmingham, Alabama

  • Teva Investigational Site 12489

    Boerne, Texas

  • Teva Investigational Site 12524

    Brooklyn, New York

  • Teva Investigational Site 12491

    Burke, Virginia

  • Teva Investigational Site 12512

    Centennial, Colorado

  • Teva Investigational Site 12504

    Charlottesville, Virginia

  • Teva Investigational Site 12477

    Cincinnati, Ohio

  • Teva Investigational Site 12525

    Cleveland, Ohio

  • Teva Investigational Site 12505

    Costa Mesa, California

  • Teva Investigational Site 12523

    Covington, Louisiana

  • Teva Investigational Site 12522

    Gainesville, Florida

  • Teva Investigational Site 12486

    Gainesville, Georgia

  • Teva Investigational Site 12514

    Greenville, South Carolina

  • Teva Investigational Site 12507

    Gresham, Oregon

  • Teva Investigational Site 12535

    Hollywood, Florida

  • Teva Investigational Site 12476

    Huntington Beach, California

  • Teva Investigational Site 12518

    Iowa City, Iowa

  • Teva Investigational Site 12497

    Lawrenceville, Georgia

  • Teva Investigational Site 12481

    Little Rock, Alaska

  • Teva Investigational Site 12519

    Los Angeles, California

  • Teva Investigational Site 12526

    Miami, Florida

  • Teva Investigational Site 12502

    Middleburg Heights, Ohio

  • Teva Investigational Site 12484

    Mission Viejo, California

  • Teva Investigational Site 12500

    Mobile, Alabama

  • Teva Investigational Site 12501

    Normal Square, Pennsylvania

  • Teva Investigational Site 12509

    Northfield, New Jersey

  • Teva Investigational Site 12478

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12487

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12506

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12474

    Orangeburg, South Carolina

  • Teva Investigational Site 12516

    Orlando, Florida

  • Teva Investigational Site 12493

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 12473

    Raleigh, North Carolina

  • Teva Investigational Site 12482

    Richmond, Virginia

  • Teva Investigational Site 12498

    Richmond, Virginia

  • Teva Investigational Site 12510

    Riverside, California

  • Teva Investigational Site 12483

    Rolling Hills Estates, California

  • Teva Investigational Site 12511

    Sacramento, California

  • Teva Investigational Site 12480

    Savannah, Georgia

  • Teva Investigational Site 12508

    Shiloh, Illinois

  • Teva Investigational Site 12479

    Spartanburg, South Carolina

  • Teva Investigational Site 12490

    Spokane, Washington

  • Teva Investigational Site 12485

    Stockton, California

  • Teva Investigational Site 12517

    Tamarac, Florida

  • Teva Investigational Site 12492

    Tulsa, Oklahoma

  • Teva Investigational Site 12488

    Upland, Pennsylvania

  • Teva Investigational Site 12527

    Vero Beach, Florida

  • Teva Investigational Site 12475

    Waco, Texas

  • Teva Investigational Site 12495

    Warrensburg, Missouri

  • Teva Investigational Site 12513

    Winter Park, Florida

Other trials in United States

Thailand1 site

  • Teva Investigational Site 12533

    Papillion, NE

Other trials in Thailand

About this study

Official title: A Three-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler (MDPI) Relative to Placebo in Pediatric Asthmatics

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
Being tested
Albuterol MDPI, Placebo, ProAir HFA inhaler
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albuterol MDPIDrug

    Also called Spiromax®

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

  • PlaceboDrug

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

  • ProAir HFA inhalerDrug

    Also called albuterol

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

Study groups in NCT02126839
Study groupRoleWhat they receive
Placebo MDPI QIDPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo; Drug: ProAir HFA inhaler
Albuterol MDPI 180 mcg QIDExperimentalAlbuterol 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.
Receives: Drug: Albuterol MDPI; Drug: ProAir HFA inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Adjusted Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks

    Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to 11 years using ATS criteria (American Thoracic Society/European Respiratory Society Statement 2007).

    Measured: 30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22

Secondary outcomes (2)

  1. Baseline Adjusted Peak Expiratory Flow (PEF) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks

    Serial PEF measurements were obtained via spirometry. PEF measures for purpose of serial PEF assessment (pre and postdose) were collected from the spirometer assessed PEF, utilizing the values from the efforts selected based on the highest of 3 acceptable FEV1 maneuvers.

    Measured: 30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22

  2. Summary of Participants With Adverse Events

    Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).

    Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02126839
Sponsor's protocol ID
ABS-AS-303
Status last verified
Nov 2021
First submitted
28 Apr 2014
Last updated
9 Nov 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 27523719

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albuterol MDPI and ProAir HFA inhaler in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Adjusted Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks (time frame: 30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02126839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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