Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers

NCT01216735 | Completed Results

• 2 other identifiers: 20070896GSK 11340
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis underlying the proposed study is that the blunted endothelium-dependent vasodilation seen in the airway of current smokers is also present in the brachial artery, and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial function in the airway of current smokers will also restore endothelium-dependent relaxation in the brachial artery. Non-smokers will be used as controls and will not receive any intervention or treatment.

Conditions

Tobacco Abuse Smoke

Keywords

smokers; inhaled corticosteroids; brachial flow; airway blood flow; albuterol; spirometry; endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo

  Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).

  3 weeks treatment period of ICS or placebo

Secondary Outcomes (1)

• Flow-mediated Brachial Vasodilation (FMD% Peak Delta)

  3 weeks of treatment

Study Arms (3)

smokers, Fluticasone first, then Placebo

ACTIVE COMPARATOR

The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) . The subjects and the investigators will be blinded to the random choice of inhaler.

Drug: Fluticasone; Drug: Placebo

smokers Placebo first, then Fluticasone

PLACEBO COMPARATOR

The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.

Drug: Fluticasone; Drug: Placebo

health non-smokers

NO INTERVENTION

The healthy non-smokers will have only visit 1 and no intervention.

Interventions

Fluticasone DRUG

220 ug twice a day for 3 weeks

Also known as: flovent

smokers Placebo first, then Fluticasone; smokers, Fluticasone first, then Placebo

Placebo DRUG

Placebo for 3 weeks

Also known as: sugar pill

smokers Placebo first, then Fluticasone; smokers, Fluticasone first, then Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For both healthy non-smokers and healthy current smokers:
• normal spirometry Healthy current smokers: history of \>10 pack-year smoking

You may not qualify if:

• Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. Cardiovascular disease and/or use of cardiovascular medications. Subjects with known beta-adrenergic agonist or nitroglycerin intolerance. A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis).
• Acute respiratory infection within four weeks prior to the study. Use of any airway medication. FEV1 \< 80% of predicted and FEV1/FVC \< 0.7. A body mass index \> 30.

Sponsors & Collaborators

• University of Miami: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Human Research Laboratory - University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (3)

• Mendes ES, Campos MA, Wanner A. Airway blood flow reactivity in healthy smokers and in ex-smokers with or without COPD. Chest. 2006 Apr;129(4):893-8. doi: 10.1378/chest.129.4.893.

  PMID: 16608935 BACKGROUND

• Mendes ES, Horvath G, Rebolledo P, Monzon ME, Casalino-Matsuda SM, Wanner A. Effect of an inhaled glucocorticoid on endothelial function in healthy smokers. J Appl Physiol (1985). 2008 Jul;105(1):54-7. doi: 10.1152/japplphysiol.90334.2008. Epub 2008 May 8.

  PMID: 18467553 BACKGROUND

• Wanner A, Campos MA, Mendes E. Airway blood flow reactivity in smokers. Pulm Pharmacol Ther. 2007;20(2):126-9. doi: 10.1016/j.pupt.2005.12.004. Epub 2006 Jan 18.

  PMID: 16414297 BACKGROUND

MeSH Terms

Interventions

Fluticasone; Sugars

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Adam Wanner, MD
• Organization: University of Miami

awanner@med.miami.edu

(305) 243-2568

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: June 29, 2016
• Results First Posted: December 5, 2014

Record last verified: 2016-05

Locations

US (1)