EmphysemaPhase 3NCT01602523
Effect of Symbicort on Sleep Quality in Patients With Emphysema
A Phase 3 study testing Budesonide/formoterol in people with Emphysema and Poor Sleep Quality, run by Temple University at 1 site in United States.
Trial summary
This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Emphysema, Poor Sleep Quality
- What is being tested?
- Budesonide/formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2014
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe emphysema (GOLD stages 2 and 3)
Who cannot join
- Use of supplemental oxygen,
- A recent COPD exacerbation within the past 4 weeks.
- A previous diagnosis of obstructive sleep apnea
- A known urinary outflow obstruction,
- Glaucoma
- History of an allergic reaction to one of the study medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple Lung Center
Philadelphia, Pennsylvania, 19140
About this study
This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.
- Conditions
- Emphysema, Poor Sleep Quality
- Being tested
- Budesonide/formoterol, Placebo
- Keywords
- Emphysema, COPD, Sleep
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterolDrug
Also called Symbicort
Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
PlaceboDrug
Placebo inhaler once daily 28 days
| Study group | Role | What they receive |
|---|---|---|
| budesonide/formoterol | Active comparator | budesonide/formoterol 160/4.5 mcg (Symbicort) Receives: Drug: Budesonide/formoterol |
| Placebo | Placebo comparator | Symbicort placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the objective assessment of sleep quality.
Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.
Measured: 28 days
Secondary outcomes (4)
Secondary outcome includes assessment of nocturnal oxygenation.
Nocturnal oxygenation will be measured by pulse oximetry.
Measured: 28 days
Secondary outcome is the subjective assessment of sleep quality.
Quality of life will be assessed by SF-36 and SGRQ-C scores.
Measured: 28 days
Secondary outcome includes assessment respiratory mechanics/function.
Respiratory function will be assessed by spirometry performed before sleep onset and upon awakening.
Measured: 28 days
Secondary outcome includes assessment of overall quality of life.
Quality of life will be assessed by SF(short form)-36 and SGRQ-C(ST George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease patients)scores.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Krachman, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602523
- Sponsor's protocol ID
- 13383
- Status last verified
- Dec 2012
- First submitted
- 23 Apr 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Symbicort on Sleep Quality in Patients With Emphysema
- ClinicalTrials.gov ID
- NCT01602523
- Acronym / sponsor ID
- 13383
- Conditions
- Emphysema, Poor Sleep Quality
- Keywords
- Emphysema, COPD, Sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 21 May 2012 (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.
This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| budesonide/formoterol | Active comparator | Drug: Budesonide/formoterolbudesonide/formoterol 160/4.5 mcg (Symbicort) |
| Placebo | Placebo comparator | Drug: PlaceboSymbicort placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe emphysema (GOLD stages 2 and 3)
Key exclusion criteria (6 listed)
- Use of supplemental oxygen,
- A recent COPD exacerbation within the past 4 weeks.
- A previous diagnosis of obstructive sleep apnea
- A known urinary outflow obstruction,
- Glaucoma
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 |
|---|---|---|
| Budesonide/formoterolAlso: SymbicortBudesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days | Drug | budesonide/formoterol |
| PlaceboPlacebo inhaler once daily 28 days | Drug | Placebo |
Primary outcome
The primary outcome is the objective assessment of sleep quality.
Time frame: 28 days
Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.
4 secondary outcomes
Secondary outcome includes assessment of nocturnal oxygenation.
Time frame: 28 days
Secondary outcome is the subjective assessment of sleep quality.
Time frame: 28 days
Secondary outcome includes assessment respiratory mechanics/function.
Time frame: 28 days
Secondary outcome includes assessment of overall quality of life.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol in people with Emphysema and Poor Sleep Quality, run by Temple 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Dec 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 primary outcome is the objective assessment of sleep quality. (time frame: 28 days). 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 7 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.