NCT01058863

Brief Summary

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5 years until next milestone

Results Posted

Study results publicly available

June 8, 2015

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

January 27, 2010

Results QC Date

May 19, 2015

Last Update Submit

November 5, 2021

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)

    FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing.

    Day 1 up to Day 30

Secondary Outcomes (2)

  • Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)

    Day 1 up to Day 30

  • Participants With Treatment-Emergent Adverse Events

    Day 1 up to Day 37

Study Arms (5)

Albuterol Spiromax® 90 mcg

EXPERIMENTAL

A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.

Drug: Albuterol Spiromax®Other: Placebo Inhaler

Albuterol Spiromax® 180 mcg

EXPERIMENTAL

A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.

Drug: Albuterol Spiromax®Other: Placebo Inhaler

ProAir® HFA 90 mcg

ACTIVE COMPARATOR

A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.

Drug: ProAir® HFAOther: Placebo Inhaler

ProAir® HFA 180 mcg

ACTIVE COMPARATOR

A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.

Drug: ProAir® HFAOther: Placebo Inhaler

Placebo Inhaler

PLACEBO COMPARATOR

Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.

Other: Placebo Inhaler

Interventions

Albuterol Spiromax®DRUG

Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.

Also known as: ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)
Albuterol Spiromax® 180 mcgAlbuterol Spiromax® 90 mcg
ProAir® HFADRUG

ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.

Also known as: albuterol HFA-MDI
ProAir® HFA 180 mcgProAir® HFA 90 mcg
Placebo InhalerOTHER

Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.

Albuterol Spiromax® 180 mcgAlbuterol Spiromax® 90 mcgPlacebo InhalerProAir® HFA 180 mcgProAir® HFA 90 mcg

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must provide written informed consent,
  • Be between 12 years of age and older,
  • Male or Female, females of non-child bearing potential or using reliable contraception
  • Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
  • Stable low dose of Inhaled Corticosteroids
  • Non-smoker, 12 months smoking-free and \<=10-pack years history
  • Otherwise healthy
  • Other criteria apply

You may not qualify if:

  • Pregnant
  • Allergic to albuterol or severe milk protein allergy
  • Must not be on another trial for 30days.
  • Other criteria apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Teva Clinical Study Site

Huntington Beach, California, 92647, United States

Location

Teva Clinical Study Site

Rolling Hills Est., California, 90274, United States

Location

Teva Clinical Study Site

San Diego, California, 92123, United States

Location

Teva Clinical Study Site

Colorado Springs, Colorado, 080907, United States

Location

Teva Clinical Study Site

Margate, Florida, 33036, United States

Location

Teva Clinical Study Site

Miami, Florida, 33173, United States

Location

Teva Clinical Study Site

St Louis, Missouri, 63141, United States

Location

Teva Clinical Study Site

Skillman, New Jersey, 08558, United States

Location

Teva Clinical Study Site

Raleigh, North Carolina, 27607, United States

Location

Teva Clinical Study Site

Cincinnati, Ohio, 45231, United States

Location

Teva Clinical Study Site

Dayton, Ohio, 45406, United States

Location

Teva Clinical Study Site

Medford, Oregon, 97504, United States

Location

Teva Clinical Study Site

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Director, Clinical Research
Organization
Teva Branded Pharmaceutical Products, R&D Inc.
ustevatrials@tevapharm.com
215-591-3000

Study Officials

  • Teva Study Leader

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 29, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 9, 2021

Results First Posted

June 8, 2015

Record last verified: 2021-11

Locations

US(13)