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COMPLETED Phase 2

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

NCT01772368 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01772368

The ClinicalTrials.gov registry entry for NCT01772368 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01772368 reports 10 study locations spanning 7 distinct geographic areas — top geographies include Texas, Oregon, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01772368?

The interventions under investigation include: Albuterol (DRUG), Fp MDPI (DRUG), FS MDPI (DRUG), Advair Diskus (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01772368?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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