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Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01391559

Last Updated: 2013-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

Brief Summary

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Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR \< 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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breathing difficulty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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arformoterol

beta-2 agonist bronchodilator

Group Type EXPERIMENTAL

arformoterol

Intervention Type DRUG

15 mcg administered via nebulizer

salmeterol

beta-2 agonist bronchodilator

Group Type ACTIVE_COMPARATOR

salmeterol

Intervention Type DRUG

50 mcg delivered vis Diskus

Interventions

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arformoterol

15 mcg administered via nebulizer

Intervention Type DRUG

salmeterol

50 mcg delivered vis Diskus

Intervention Type DRUG

Other Intervention Names

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Brovana Serevent

Eligibility Criteria

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Inclusion Criteria

* male or female patient 60 years of age or older; diagnosis of COPD; current or former smoker; previous or current use of Diskus device; PIFR \< 60 l/min using the In-check DIAL against the resistance of the Diskus device; clinically stable.

Exclusion Criteria

* any patient who has a concomitant disease that might interfere with study procedures or evaluation; inability to withhold short-acting and long-acting bronchodilators on the days of testing
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald A Mahler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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Janssens W, VandenBrande P, Hardeman E, De Langhe E, Philps T, Troosters T, Decramer M. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur Respir J. 2008 Jan;31(1):78-83. doi: 10.1183/09031936.00024807. Epub 2007 Sep 26.

Reference Type BACKGROUND
PMID: 17898020 (View on PubMed)

Mahler DA, Waterman LA, Ward J, Gifford AH. Comparison of dry powder versus nebulized beta-agonist in patients with COPD who have suboptimal peak inspiratory flow rate. J Aerosol Med Pulm Drug Deliv. 2014 Apr;27(2):103-9. doi: 10.1089/jamp.2013.1038. Epub 2013 Jun 8.

Reference Type DERIVED
PMID: 23745526 (View on PubMed)

Other Identifiers

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CPHS22812

Identifier Type: -

Identifier Source: org_study_id