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NCT01747629 · ClinicalTrials.gov registry record · Phase 3

Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
160
Enrollment target

NCT01747629: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT01747629 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01747629, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
160 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Primary Outcome

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessme

Interventions

  • DRUG Placebo MDPI
  • DRUG Albuterol MDPI

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2012-12
Est. Completion 2013-11
Phase Phase 3

What the finished NCT01747629 record still lists

NCT01747629 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo MDPI is the first listed.

NCT01747629 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01747629 about?

NCT01747629 is a clinical study titled "Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics". The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

What is the current status of trial NCT01747629?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2012-12. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01747629?

The interventions under investigation include: Placebo MDPI (DRUG), Albuterol MDPI (DRUG).

Who is sponsoring clinical trial NCT01747629?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01747629's enrollment target sits among peer trials

160 1479th of 2000 higher than 500 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01747629, the US trial registry maintained by the National Library of Medicine. NCT01747629 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.