COPDPhase 4NCT00731770
Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
A Phase 4 study testing Advair 250 and Advair 250 - matched in people with COPD, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Advair 250 and Advair 250 - matched
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate to severe COPD as per GOLD criteria
- Insomnia, poor sleep, non-restorative sleep or daytime sleepiness by history
- Age 45 to 75 years, male or female
- FEV1 below 80% of predicted using CRAPO
- FEV1/FVC < 70% predicted
- Past or present tobacco smoker
- Female patients must be postmenopausal for 1 year or be willing to use birth control or abstain from sex.
Who cannot join
- Asthma
- Use of oral or injectable corticosteroids within 2 months
- Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)
- Lung or heart disease except for COPD
- Deviated nasal septum, nasal polyps or anatomic obstruction of the nose
- Obesity defined as BMI >30kg/m2
Show all 13Show fewer
- Inability to tolerate or history of allergy to long acting beta agonist or inhaled corticosteroid therapy.
- Inability to complete a 2 week run-in with albuterol prn as only therapy
- Use of narcotics, sleep aids, sedating antihistamines, sedatives, MAO Inhibitors, and other medications known to affect daytime somnolence or sleep quality
- Excessive use of alcohol or use of "recreational drugs"
- Use of narcotics, sleep aids, sedatives or sedating antihistamines.
- Night shift workers
- Women who are breast feeding or pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TITLE: Double-blinded, Double-dummy, Study Comparing Fluticasone-salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.
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.
Read more
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Advair 250, Placebo- matched, Placebo, Advair 250 - matched
- Keywords
- COPD, sleep, daytime somnolence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advair 250Drug
Also called fluticasone/salmeterol 250/50
1 puff bid inhaled
Placebo- matchedDrug
1 puff bid inhaled
PlaceboDrug
Placebo 1 puff bid inhaled
Advair 250 - matchedDrug
Also called fluticasone/salmeterol 250/50
i puff bid inhaled
| Study group | Role | What they receive |
|---|---|---|
| Placebo, then Advair 250- matched | Placebo comparator | 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. Receives: Drug: Advair 250; Drug: Placebo- matched |
| Advair 250, then Placebo- matched | Active comparator | 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. Receives: Drug: Placebo; Drug: Advair 250 - matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Daytime Somnolence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Timothy Craig, Milton S. Hershey Medical Center
- Investigators
- Timothy Craig, DO, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731770
- Sponsor's protocol ID
- IRB 29024
- Status last verified
- Mar 2019
- First submitted
- 7 Aug 2008
- Last updated
- 29 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TITLE: Double-blinded, Double-dummy, Study Comparing Fluticasone-salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.
- ClinicalTrials.gov ID
- NCT00731770
- Acronym / sponsor ID
- IRB 29024
- Conditions
- COPD
- Keywords
- COPD, sleep, daytime somnolence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2009 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo, then Advair 250- matched | Placebo comparator | Drug: Advair 250, Drug: Placebo- matched1 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. |
| Advair 250, then Placebo- matched | Active comparator | Drug: Placebo, Drug: Advair 250 - matched1 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with moderate to severe COPD as per GOLD criteria
- Insomnia, poor sleep, non-restorative sleep or daytime sleepiness by history
- Age 45 to 75 years, male or female
- FEV1 below 80% of predicted using CRAPO
- FEV1/FVC < 70% predicted
Key exclusion criteria (13 listed)
- Asthma
- Use of oral or injectable corticosteroids within 2 months
- Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)
- Lung or heart disease except for COPD
- Deviated nasal septum, nasal polyps or anatomic obstruction of the nose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advair 250Also: fluticasone/salmeterol 250/501 puff bid inhaled | Drug | Placebo, then Advair 250- matched |
| Placebo- matched1 puff bid inhaled | Drug | Placebo, then Advair 250- matched |
| PlaceboPlacebo 1 puff bid inhaled | Drug | Advair 250, then Placebo- matched |
| Advair 250 - matchedAlso: fluticasone/salmeterol 250/50i puff bid inhaled | Drug | Advair 250, then Placebo- matched |
Primary outcome
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
1 secondary outcome
Daytime Somnolence
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Craig, DO principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advair 250 and Advair 250 - matched in people with COPD, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.