Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

NCT00571428 | Completed Phase 4 Results

• 1 other identifier: 091-903
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Chronic Bronchitis; Emphysema

Outcome Measures

Primary Outcomes (1)

• Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours

  Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.

  0-24 hours post dose

Secondary Outcomes (13)

• Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours

  0-12 hours

• Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours

  12-24 hours

• Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point

  pre-dose and 24 hours post-dose

• Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose

  pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose

• Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose

  Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose

Study Arms (2)

15 mcg BID / 30 mcg QD

EXPERIMENTAL

Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit.

Drug: Arformoterol Tartrate Inhalation Solution; Drug: Placebo

30 mcg QD / 15 mcg BID

EXPERIMENTAL

Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.

Drug: Arformoterol Tartrate Inhalation Solution; Drug: Placebo

Interventions

Arformoterol Tartrate Inhalation Solution DRUG

Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)

Also known as: Brovana

15 mcg BID / 30 mcg QD; 30 mcg QD / 15 mcg BID

Placebo DRUG

Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

15 mcg BID / 30 mcg QD; 30 mcg QD / 15 mcg BID

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects must be at least 45 years old at the time of consent.
• Subjects must have a pre-established primary clinical diagnosis of COPD.
• Subjects must have a baseline FEV1 of ≤ 65% of predicted normal value at Visit 1.
• Subjects must have a FEV1 ≥ 0.70L at Visit 1.
• Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.

You may not qualify if:

• Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Screening.
• Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (4)

Unknown Facility

Medford, Oregon, 97504, United States

Location

Unknown Facility

Portland, Oregon, 97213, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (1)

• Panettieri RA Jr, MacIntyre N, Sims M, Kerwin E, Fogarty C, Noonan M, Claus R, Andrews WT. Comparison of the efficacy and safety of arformoterol 15 microg twice daily and arformoterol 30 microg once daily in COPD: a single-dose, multicenter, randomized, modified-blind, two-way crossover study. Clin Ther. 2009 Aug;31(8):1716-23. doi: 10.1016/j.clinthera.2009.08.012.

  PMID: 19808130 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Limitations and Caveats

Single day/dose; small numbers of subjects; difference between arms (2mL vs 4mL per dose); Predefined +/-0.07L equivalence is arbitrarily lower than the clinically recognized 0.1L. Hence, clinical efficacy \& safety conclusions are difficult to reach.

Results Point of Contact

• Title: Brovana Medical Director
• Organization: Sunovion

1-866-503-6351

Study Officials

• Pulmonary Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 22, 2012
• Results First Posted: July 2, 2009

Record last verified: 2012-02

Locations

US (4)