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Trial record 37 of 318 for:    FLUTICASONE AND SALMETEROL

Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep

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ClinicalTrials.gov Identifier: NCT00731770
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Timothy Craig, Milton S. Hershey Medical Center

Brief Summary:

Fluticasone (Advair), an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD. Fluticasone/salmeterol has been shown to significantly improve forced expiratory volume (FEV1) and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled corticosteroids have been shown to decrease frequency of COPD exacerbations (Gartlehner et al. 2006) and long acting bronchodilators demonstrated a reduction in dyspnea, increased airflow and reduction in hyperinflation in patients with symptomatic COPD (Ramirez-Venegas et al. 1997). Specifically, salmeterol has also been shown to have a positive effect on symptoms and health status of patients with COPD when added to usual treatment (Stockley et al. 2006).

Previous research of subjects from our group with asthma has shown salmeterol to be associated with sustained improvements in morning peak expiratory flow (PEF), protection from nighttime lung function deterioration and improvement in patient perception of sleep (Wiegand et al. 1999). This study has not been performed in patients with COPD nor has the effect of salmeterol with fluticasone on sleep quality been assessed.

AIM: The aim of this study is to determine the effect of fluticasone/salmeterol on sleep quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on sleep.

The hypothesis is that there would be a significant improvement in sleep quality when patients are placed on fluticasone/salmeterol as compared to placebo.


Condition or disease Intervention/treatment Phase
COPD Drug: Advair 250 Drug: Placebo- matched Drug: Placebo Drug: Advair 250 - matched Phase 4

Detailed Description:

RATIONALE:

Chronic obstructive pulmonary disease (COPD) is a term that describes a disease state in which there is chronic irreversible airflow limitation. It has been well documented that patients with COPD have disturbed sleep. Certain published reports suggest that more than 50% of COPD patients have sleep complaints (George et al., Drugs, 2003). These patients are found to have sleep onset latency and poor sleep maintenance. While their sleep disturbance may be explained in part by side effects of medications, it could also be a result of nocturnal gas exchange abnormalities (Knutty 2004). In COPD there is worsening hypoxemia and hypercapnia during sleep, particularly rapid eye movement (REM) sleep, and sleep disturbance seems to be worse with more severe COPD. It is commonly believed that optimizing medical management of the disease is important in improving the sleep quality of these patients and thus leading to improved quality of life.

Fluticasone, an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD. Fluticasone/salmeterol has been shown to significantly improve FEV1 and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled corticosteroids have been shown to decrease frequency of COPD exacerbations (Gartlehner et al. 2006) and long acting bronchodilators demonstrated a reduction in dyspnea, increased airflow and reduction in hyperinflation in patients with symptomatic COPD (Ramirez-Venegas et al. 1997). Specifically, salmeterol has also been shown to have a positive effect on symptoms and health status of patients with COPD when added to usual treatment (Stockley et al. 2006).

Previous research of subjects from our group with asthma has shown salmeterol to be associated with sustained improvements in morning PEF, protection from nighttime lung function deterioration and improvement in patient perception of sleep (Wiegand et al. 1999). This study has not been performed in patients with COPD nor has the effect of salmeterol with fluticasone on sleep quality been assessed.

AIM:

The aim of this study is to determine the effect of fluticasone/salmeterol on sleep quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on sleep.

The hypothesis is that there would be a significant improvement in sleep quality when patients are placed on fluticasone/salmeterol as compared to placebo.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: TITLE: Double-blinded, Double-dummy, Study Comparing Fluticasone-salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.
Actual Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo, then Advair 250- matched
1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.
Drug: Advair 250
1 puff bid inhaled
Other Name: fluticasone/salmeterol 250/50

Drug: Placebo- matched
1 puff bid inhaled

Active Comparator: Advair 250, then Placebo- matched
1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.
Drug: Placebo
Placebo 1 puff bid inhaled

Drug: Advair 250 - matched
i puff bid inhaled
Other Name: fluticasone/salmeterol 250/50




Primary Outcome Measures :
  1. The Aim of This Study is to Determine the Effect of Fluticasone/Salmeterol on Sleep Quality in Patients With COPD and to Compare Efficacy of Advair 250 Compared to Placebo on Sleep. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Daytime Somnolence [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with moderate to severe COPD as per GOLD criteria
  2. Insomnia, poor sleep, non-restorative sleep or daytime sleepiness by history
  3. Age 45 to 75 years, male or female
  4. FEV1 below 80% of predicted using CRAPO
  5. FEV1/FVC < 70% predicted
  6. Past or present tobacco smoker
  7. Female patients must be postmenopausal for 1 year or be willing to use birth control or abstain from sex.

Exclusion Criteria:

  1. Asthma
  2. Use of oral or injectable corticosteroids within 2 months
  3. Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)
  4. Lung or heart disease except for COPD
  5. Deviated nasal septum, nasal polyps or anatomic obstruction of the nose
  6. Obesity defined as BMI >30kg/m2
  7. Inability to tolerate or history of allergy to long acting beta agonist or inhaled corticosteroid therapy.
  8. Inability to complete a 2 week run-in with albuterol prn as only therapy
  9. Use of narcotics, sleep aids, sedating antihistamines, sedatives, MAO Inhibitors, and other medications known to affect daytime somnolence or sleep quality
  10. Excessive use of alcohol or use of "recreational drugs"
  11. Use of narcotics, sleep aids, sedatives or sedating antihistamines.
  12. Night shift workers
  13. Women who are breast feeding or pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731770


Locations
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United States, Pennsylvania
Penn State Universuty
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
GlaxoSmithKline
Investigators
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Principal Investigator: Timothy Craig, DO Penn State University

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Responsible Party: Timothy Craig, Timothy Craig, D.O., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00731770     History of Changes
Other Study ID Numbers: IRB 29024
First Posted: August 11, 2008    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Timothy Craig, Milton S. Hershey Medical Center:
COPD
sleep
daytime somnolence
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics