Chronic Obstructive Pulmonary DiseaseAQuOS-COPDNCT00741767
The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD
A study testing salmeterol-fluticasone in people with Chronic Obstructive Pulmonary Disease and Sleep Disorders, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Sleep Disorders
- What is being tested?
- salmeterol-fluticasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years of age
- BMI<30
- Former smokers with ≥ 10 pack-year history
- Diagnosis of COPD, as defined by the American Thoracic Society (FEV1/FVC < 70 with history of exposure to noxious particles or gases)
- Moderate to severe COPD as defined as an FEV1 ≤ 80% predicted
- Functional residual capacity > 120% or inspiratory capacity < 80% predicted on pulmonary function testing
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- Poor subjective sleep quality: All subjects included must answer "yes" to at least one of the following questions:
- Do you have trouble falling asleep?
- Do you have trouble staying asleep?
- Do you not get enough sleep?
- Do you wake up too early and not be able to get back to sleep?
- Do you fall asleep during the day?
Who cannot join
- Conditions that in the judgment of the investigator would interfere with subject participation in the study
- BMI > 30
- History of or physician diagnosed pulmonary disorder other than COPD
- History of significant obstructive sleep disordered breathing (apnea-hypopnea index > 15) or presence of central sleep apnea
- History of narcolepsy, primary hypersomnia, periodic limb movement disorder, or parasomnia
- History of psychiatric illness
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- Presence of decompensated heart failure
- Use of prednisone, antibiotic therapy, or new medication for COPD in the previous 3 months
- Use of any sleep aids
- History of ≥ 1 COPD exacerbation (defined as requiring oral corticosteroids and/or antibiotics as either an outpatient or inpatient)
- Known allergy or significant adverse reactions to inhaled beta2-agonists and inhaled corticosteroids (not including thrush and dysphonia)
- Pregnancy or lactating
- Inability or unwillingness to provide informed consent
- Inability to effectively use study medication or perform baseline measurements
- Inability to be contacted by phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (Advair and Quality of Sleep in COPD)
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a common and clinically important disease characterized by chronic, irreversible airflow obstruction. Poor sleep quality and insomnia are well described phenomena in patients with COPD. Several studies suggest sleep disturbance adversely affects quality of life and may worsen daytime pulmonary function in COPD patients. Improving sleep quality in patients with COPD, therefore, may not only improve health quality, but also attenuate the decline in daytime pulmonary function.
Previous studies investigating the effects of inhaled bronchodilators on sleep quality in COPD have shown conflicting results. These conflicting data prompted us to perform a retrospective study on patients with COPD and co-existing sleep apnea (OSA) investigating the effects of mechanical lung function impairment and lung hyperinflation on sleep. Our study found a significant correlation between increased lung hyperinflation and reduced sleep efficiency (a measure of sleep quality), and this relationship was preserved in a multivariable regression model.
We hypothesize that Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD. To test this hypothesis, we propose a double-blinded, placebo controlled cross-over study of Advair Diskus in patients with COPD and lung hyperinflation.
It was mutually decided by the sponsor and principal investigator to terminate the study early due to study subject enrollment difficulties.
- Being tested
- salmeterol-fluticasone
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Sleep, Sleep quality, Lung hyperinflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salmeterol-fluticasoneDrug
Also called Advair Diskus
250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol-fluticasone | Other | Patients randomized to receive salmeterol-fluticasone 250/50 twice daily for 4 weeks. Patients will cross-over and receive placebo medication for 4 weeks later in the study. Receives: Drug: salmeterol-fluticasone |
| Placebo | Other | Patients randomized to receive placebo medication twice daily for 4 weeks. Patients will cross-over and receive study medication later in the study. Receives: Drug: salmeterol-fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective measures of sleep quality
Measured: 16 weeks
Changes in objective measures of sleep and daytime cognitive function
Measured: 16 weeks
Secondary outcomes (1)
Changes in lung hyperinflation and systemic inflammation
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2010 (estimated)
- Study completionFeb 2012
Why it stopped: Study subject enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Ravi Kalhan, Northwestern University
- Investigators
- Ravi Kalhan, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741767
- Sponsor's protocol ID
- 3582
- Acronym
- AQuOS-COPD
- Status last verified
- Oct 2015
- First submitted
- 22 Aug 2008
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (Advair and Quality of Sleep in COPD)
- ClinicalTrials.gov ID
- NCT00741767
- Acronym / sponsor ID
- AQuOS-COPD / 3582
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Sleep, Sleep quality, Lung hyperinflation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study subject enrollment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a common and clinically important disease characterized by chronic, irreversible airflow obstruction. Poor sleep quality and insomnia are well described phenomena in patients with COPD. Several studies suggest sleep disturbance adversely affects quality of life and may worsen daytime pulmonary function in COPD patients. Improving sleep quality in patients with COPD, therefore, may not only improve health quality, but also attenuate the decline in daytime pulmonary function.
Previous studies investigating the effects of inhaled bronchodilators on sleep quality in COPD have shown conflicting results. These conflicting data prompted us to perform a retrospective study on patients with COPD and co-existing sleep apnea (OSA) investigating the effects of mechanical lung function impairment and lung hyperinflation on sleep. Our study found a significant correlation between increased lung hyperinflation and reduced sleep efficiency (a measure of sleep quality), and this relationship was preserved in a multivariable regression model.
We hypothesize that Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD. To test this hypothesis, we propose a double-blinded, placebo controlled cross-over study of Advair Diskus in patients with COPD and lung hyperinflation.
It was mutually decided by the sponsor and principal investigator to terminate the study early due to study subject enrollment difficulties.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmeterol-fluticasone | Other | Drug: salmeterol-fluticasonePatients randomized to receive salmeterol-fluticasone 250/50 twice daily for 4 weeks. Patients will cross-over and receive placebo medication for 4 weeks later in the study. |
| Placebo | Other | Drug: salmeterol-fluticasonePatients randomized to receive placebo medication twice daily for 4 weeks. Patients will cross-over and receive study medication later in the study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 40 years of age
- BMI<30
- Former smokers with ≥ 10 pack-year history
- Diagnosis of COPD, as defined by the American Thoracic Society (FEV1/FVC < 70 with history of exposure to noxious particles or gases)
- Moderate to severe COPD as defined as an FEV1 ≤ 80% predicted
Key exclusion criteria (15 listed)
- Conditions that in the judgment of the investigator would interfere with subject participation in the study
- BMI > 30
- History of or physician diagnosed pulmonary disorder other than COPD
- History of significant obstructive sleep disordered breathing (apnea-hypopnea index > 15) or presence of central sleep apnea
- History of narcolepsy, primary hypersomnia, periodic limb movement disorder, or parasomnia
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 |
|---|---|---|
| salmeterol-fluticasoneAlso: Advair Diskus250ug salmeterol/50ug fluticasone inhaled via an oral inhaler twice daily | Drug | Placebo, Salmeterol-fluticasone |
Primary outcome
Changes in subjective measures of sleep quality
Time frame: 16 weeks
Changes in objective measures of sleep and daytime cognitive function
Time frame: 16 weeks
1 secondary outcome
Changes in lung hyperinflation and systemic inflammation
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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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.
Ravi Kalhan, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salmeterol-fluticasone in people with Chronic Obstructive Pulmonary Disease and Sleep Disorders, run by Northwestern University 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 12 inclusion and 15 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: withdrawn, as of the sponsor's last update on 6 Oct 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changes in subjective measures of sleep quality (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 6 Oct 2015.