Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

NCT00387036 | Terminated Phase 2 Results

• 3 other identifiers: 0000-0360362006_039
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Standardized Dyspnea Score at Isotime During Exercise

  Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 \[Best\] - 10 \[Worst\] ).

  2 Weeks

Secondary Outcomes (1)

• Exercise Endurance Time

  2 Weeks

Study Arms (2)

1

OTHER

Arm 1: drug, crossing over to Pbo comparator

Drug: Fluticasone

2

OTHER

Arm 2: Pbo comparator, crossing over to drug

Drug: Fluticasone; Drug: Comparator: Placebo

Interventions

Fluticasone DRUG

fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.

1; 2

Comparator: Placebo DRUG

Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Clinical diagnosis of COPD for greater than one year
• History of cigarette smoking

You may not qualify if:

• Other lung diseases (not including COPD), such as asthma
• A condition that could interfere with your ability to perform exercise tests

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respir Med. 2011 Dec;105(12):1836-45. doi: 10.1016/j.rmed.2011.08.021. Epub 2011 Sep 13.

  PMID: 21917440 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

clinicaltrialsdisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 12, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 21, 2016
• Results First Posted: May 26, 2010

Record last verified: 2015-12