Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
Public ClinicalTrials.gov record NCT01049360. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
Study identification
- NCT ID
- NCT01049360
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Interventions
- Aclidinium 400 μg / Formoterol 12 μg Drug
- Aclidinium 400 μg / Formoterol 6 μg Drug
- Aclidinium 400 μg Drug
- Formoterol 12 μg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2009 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Aug 2010 (Actual)
- Last update posted
- Feb 28, 2017
2009 – 2010
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 0909 | Glendale | Arizona | 85306 | — |
| Forest Investigative Site 2050 | Pheonix | Arizona | 85006 | — |
| Forest Investigative Site 2029 | Rancho Mirage | California | 92270 | — |
| Forest Investigative Site 1084 | Stockton | California | 95207 | — |
| Forest Investigative Site 2045 | Wheat Ridge | Colorado | 80033 | — |
| Forest Investigative Site 1152 | Clearwater | Florida | 33765 | — |
| Forest Investigative Site 2053 | Tampa | Florida | 33603 | — |
| Forest Investigative Site 2047 | Tampa | Florida | 33613 | — |
| Forest Investigative Site 1431 | North Dartmouth | Massachusetts | 02747 | — |
| Forest Investigative Site 2084 | Summit | New Jersey | 07901 | — |
| Forest Investigative Site 1119 | Elmira | New York | 14901 | — |
| Forest Investigative Site 2035 | Elizabeth City | North Carolina | 27909 | — |
| Forest Investigative Site 1153 | Raleigh | North Carolina | 27607 | — |
| Forest Investigative Site 2028 | Cincinnati | Ohio | 45242 | — |
| Forest Investigative Site 2043 | Medford | Oregon | 97504 | — |
| Forest Investigative Site 1106 | Portland | Oregon | 97213 | — |
| Forest Investigative Site 1089 | East Providence | Rhode Island | 02914 | — |
| Forest Investigative Site 1121 | Spartanburg | South Carolina | 29303 | — |
| Forest Investigative Site 1498 | San Antonio | Texas | 78215 | — |
| Forest Investigative Site 1129 | Waco | Texas | 76712 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01049360, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 28, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01049360 live on ClinicalTrials.gov.