The Effect of Fluticasone/Salmeterol Combination on Exertional Breathlessness in Patients With Mild COPD

NCT00559312 | Completed DMC

• 1 other identifier: SCO110755
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Even patients with milder COPD can have significant physiological abnormalities which become more pronounced during exercise, leading to intolerable breathing discomfort (dyspnea). While there is a compelling physiological rationale for the efficacy of inhaled corticosteroid/long-acting bronchodilator combination therapy \[i.e., fluticasone 250μg/salmeterol 50μg (FSC250/50)\] in moderate to severe COPD, little information is available on the potential impact of this therapy in milder symptomatic disease. This study will be the first to explore mechanisms of dyspnea and activity limitation in milder COPD and will determine if there is a sound physiological rationale for the use of FSC as therapy for this subpopulation.

Conditions

COPD

Keywords

mild COPD; dyspnea; exercise; combination therapy

Outcome Measures

Primary Outcomes (1)

• Dyspnea intensity (Borg rating at a standardized time during exercise)

  6 weeks

Secondary Outcomes (3)

• Exercise endurance time

  6 weeks

• Measurements of small airway function

  6 weeks

• Exercise measurements of ventilation, breathing pattern, operating lung volumes and respiratory mechanics

  6 weeks

Study Arms (2)

FSC 250/50

EXPERIMENTAL

fluticasone 250μg/salmeterol 50μg combination

Drug: fluticasone/salmeterol combination

Placebo

PLACEBO COMPARATOR

matched placebo inhaler

Drug: placebo

Interventions

fluticasone/salmeterol combination DRUG

Diskus inhaler, fluticasone 250μg/salmeterol 50μg, twice daily, 6-week duration

Also known as: Advair 250/50

FSC 250/50

placebo DRUG

Placebo Diskus inhaler, twice daily, 6-week duration

Placebo

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable mild COPD,
• FEV1/FVC\<0.7 and FEV1\>60% predicted,
• Activity-related dyspnea (i.e., Baseline Dyspnea Index focal score \<9, MRC dyspnea scale \>2),
• Cigarette smoking history ≥20 pack-years.

You may not qualify if:

• Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation,
• Important contraindications to clinical exercise testing,
• Use of daytime oxygen,
• History of Asthma.

Sponsors & Collaborators

• Queen's University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Denis E O'Donnell, MD, FRCPC

  Queen's University and Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

CA (1)