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NCT01772368 · ClinicalTrials.gov registry record · Phase 2

Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects

A Phase 2 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 2
Development phase
72
Enrollment target
10
Study locations

NCT01772368 is a Phase 2 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 72 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The trial reports 10 study locations across 7 states.

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The verdict

NCT01772368, a Phase 2 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 2
Development phase
72 participants
Enrollment target
10
Study locations

Study Summary

The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.

Conditions Studied

Interventions

  • DRUG Albuterol
  • DRUG Fp MDPI
  • DRUG FS MDPI
  • DRUG Advair Diskus

Study Locations (10)

Texas

  • Teva Investigational Site 10457 - El Paso
  • Teva Investigational Site 10450 - New Braunfels
  • Teva Investigational Site 10456 - San Antonio

Oregon

  • Teva Investigational Site 10451 - Medford
  • Teva Investigational Site 10449 - Portland

Colorado

  • Teva Investigational Site 10453 - Denver

Massachusetts

  • Teva Investigational Site 10452 - North Dartmouth

Missouri

  • Teva Investigational Site 10455 - St Louis

New Jersey

  • Teva Investigational Site 10454 - Skillman

North Carolina

  • Teva Investigational Site 10448 - Raleigh

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2013-01
Est. Completion 2013-06
Phase Phase 2

What the Registry Record Tells You About NCT01772368

The ClinicalTrials.gov registry entry for NCT01772368 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Albuterol is the first listed.

NCT01772368 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Texas, Oregon, Colorado.

Frequently Asked Questions

What is clinical trial NCT01772368 about?

NCT01772368 is a clinical study titled "Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects". The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS ...

What is the current status of trial NCT01772368?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2013-01. Estimated completion is 2013-06.

What conditions does trial NCT01772368 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT01772368?

The interventions under investigation include: Albuterol (DRUG), Fp MDPI (DRUG), FS MDPI (DRUG), Advair Diskus (DRUG).

Who is sponsoring clinical trial NCT01772368?

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

Where is trial NCT01772368 being conducted?

This trial has 10 study locations across Colorado, Massachusetts, Missouri, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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