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Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)

NCT02796651 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2018-02-07

Study results available
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Summary

To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).

Conditions

  • Chronic Obstructive Pulmonary Disease - COPD

Interventions

DRUG

Formoterol fumarate (6 μg)

Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)

DRUG

Formoterol furmarate (20 μg)

Oral Inhalation (via a standard jet nebulizer connected to an air compressor.

DRUG

Placebo for formoterol fumarate

Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)

DRUG

Formoterol fumarate (12 μg)

Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)

DRUG

Formoterol fumarate (40 μg)

Oral Inhalation (via a standard jet nebulizer connected to an air compressor.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Mark H. Gotfried, MD · 1112 East McDowell Road, Phoenix, AZ 85006, United States.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-07
Completion
2016-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796651 on ClinicalTrials.gov