NCT00530062 is a Phase 4 clinical trial of Albuterol-HFA-MDI in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D, Inc..

Who is sponsoring NCT00530062?

NCT00530062 is sponsored by Teva Branded Pharmaceutical Products R&D, Inc..

What drugs are being tested in NCT00530062?

Interventions in NCT00530062: Albuterol-HFA-MDI, Albuterol-HFA-BAI.

Is NCT00530062 still recruiting?

NCT00530062 is currently completed. Last updated 7 September 2022.

Are results published for NCT00530062?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-07 · How we verify

NCT00530062

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma

Completed Phase 4 Results posted Last updated 7 September 2022

What this trial tests

Phase 4 trial testing Albuterol-HFA-MDI in Asthma in 49 participants. Completed in 24 October 2008.

Timeline

25 July 2007

Primary endpoint
24 October 2008

24 October 2008

Quick facts

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	25 July 2007
Primary completion	24 October 2008
Estimated completion	24 October 2008
Sites	5 locations across United States

Drugs / interventions tested

Albuterol-HFA-MDI — full drug profile →
Albuterol-HFA-BAI — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. — full company profile →

Who can join

Adults 7 to 70, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2 Primary · Baseline, Up to 2 hours postdose

The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.

Group	Value	95% CI
Albuterol-HFA-BAI	21.403	± 2.263
Albuterol-HFA-MDI	20.457	± 2.253

Percent Change From Baseline in FEV1 Within 30 Minutes Postdose Secondary · Baseline up to 30 minutes postdose

The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.

Group	Value	95% CI
Albuterol-HFA-BAI	10.777	± 1.185
Albuterol-HFA-MDI	10.114	± 1.180

Percent Change From Baseline in FEV1 up to 2 Hours Postdose Secondary · Baseline up to 2 hours postdose

The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.

Group	Value	95% CI
Albuterol-HFA-BAI	14.319	± 1.292
Albuterol-HFA-MDI	13.731	± 1.286

Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2 Secondary · Baseline up to 2 hours postdose

The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The test-day baseline consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.

Group	Value	95% CI
Albuterol-HFA-BAI	0.443	± 0.044
Albuterol-HFA-MDI	0.407	± 0.044

Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose Secondary · Baseline up to 2 hours postdose

Group	Value	95% CI
Albuterol-HFA-BAI	57.1
Albuterol-HFA-MDI	42.9

Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose Secondary · Baseline up to 2 hours postdose

Group	Value	95% CI
Albuterol-HFA-BAI	32.7
Albuterol-HFA-MDI	30.6

Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose Secondary · Baseline up to 2 hours postdose

The number of minutes required for the baseline FEV1 to increase by at least 12% within the 2-hour observation period. Median time and corresponding confidence intervals (CIs) were obtained via the Kaplan-Meier estimate.

Group	Value	95% CI
Albuterol-HFA-BAI	60.00	45.00 – NA
Albuterol-HFA-MDI	NA	46.00 – NA

Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose Secondary · Baseline up to 2 hours postdose

The number of minutes required for the baseline FEV1 to increase by at least 15% within the 2-hour observation period. Median time and corresponding CIs were obtained via the Kaplan-Meier estimate.

Group	Value	95% CI
Albuterol-HFA-BAI	NA	123.0 – NA
Albuterol-HFA-MDI	NA	NA – NA

Time to Maximum Increase in FEV1 Secondary · Baseline up to 2 hours postdose

Each calculation for FEV1 took several minutes in order to obtain the highest of 3 measurements. The total collection time exceeded the 120 mins post-dose time frame for some participants.

Group	Value	95% CI
Albuterol-HFA-BAI	48.00	15.00 – 123.0
Albuterol-HFA-MDI	45.00	11.00 – 128.0

Sponsor's own description

This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Teva Branded Pharmaceutical Products R&D, Inc. trials

Trials by the same sponsor.

NCT06664619 — A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate · Phase 3 · recruiting
NCT06627231 — Mass Balance Clinical Trial With TEV-56286 · Phase 1 · completed
NCT06480552 — An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Co · Phase 1 · recruiting
NCT06290102 — Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluti · Phase 1 · completed
NCT06253546 — Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00530062 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 7 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00530062.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing