Pulmonary Disease, Chronic ObstructivePhase 4NCT00633217

Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)

A Phase 4 study testing Fluticasone Propionate/Salmeterol DISKUS 250/50mcg and Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg and Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 16 sitesUnited States
Study dates: Mar 2008to Feb 2009
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects eligible for enrollment in the study must meet all of the following criteria:
Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
Males or females ≥ 40 years of age.
A female is eligible to participate in this study if she is of:
non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal [i.e., >1 year without menses in the absence of hormone replacement therapy]); or,
child-bearing potential, has a negative pregnancy test (urine) at screen, and one of the following applies:

Show all 18Show fewer

Abstinence from intercourse, or,
Male partner was sterile prior to the female subject's entry into the study, or,
Use of implants of levonorgestrel; or,
Injectable progesterone; or,
Oral contraceptive (combined or progesterone only), contraceptive patch, vaginal ring; or,
Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (e.g., Paragard), or,
Double barrier technique simultaneously using two of the following: spermicide, male condom, diaphragm, or female condom
An established clinical history of COPD (including chronic bronchitis and/or emphysema) in accordance with the following definition by the American Thoracic Society:
COPD is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences [Celli, 2004].
A post-albuterol FEV1/FVC ratio of ≤ 0.70
A post-albuterol FEV1 ≥ 0.70L and ≤ 70% of predicted normal OR a post-albuterol FEV1 of ≤ 0.70L and ≥40% of predicted normal but still ≤70% of predicted normal based on NHANES III reference values [Hankinson, 1999].
Current or previous smokers with a cigarette smoking history of ≥ 10 pack-years. [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Former-smokers are defined as subjects who have discontinued smoking for ≥ 6 months prior to Visit 1. Subjects who decide to stop smoking at Visit 1 will not be eligible for participation in the study.

Who cannot join

Subjects meeting any of the following criteria must not be enrolled in the study:
A current diagnosis of asthma.
Any clinically significant and uncontrolled disease, including but not limited to the following: neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would affect the efficacy analysis if the disease/condition exacerbated during the study.
A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency. Allergic rhinitis is not exclusionary.
An abnormal and clinically significant chest x-ray or computed tomography (CT) scan not believed to be due to the presence of COPD. A chest x-ray must be taken if the subject has not had one within 6 months of Visit 1.
An abnormal and clinically significant 12-lead electrocardiogram (ECG). For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:

Show all 26Show fewer

Myocardial ischemia
Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) The study investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study.
Previously diagnosed cancer unless it is in complete clinical remission (no evidence of any tumor burden) at Visit 1. Localized carcinomas of the skin that have been resected for cure are not considered exclusionary.
Any immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or intranasal, inhaled, or oral corticosteroid including any components of the formulations (e.g. lactose or milk protein).
Initiation of systemic beta-blocker medications within 30 days of Visit 1.
Use of products containing the protease inhibitor ritonavir (Norvir, Kaletra).
Use of the following medications within the defined times prior to Visit 1:
Medication (Exclusion Prior to Visit 1) Short-acting beta-agonists (e.g., albuterol) (6 hours) Ipratropium (6 hours) Ipratropium/albuterol combination product (6 hours) Oral beta-agonists (48 hours) Salmeterol and formoterol (48 hours) Theophylline preparations (48 hours) Tiotropium (48 hours) Long-acting beta-agonist/inhaled corticosteroid combination products (e.g., ADVAIR™ or Symbicort) (30 days) Inhaled corticosteroids (30 days) Oral or parenteral corticosteroids (30 days) Any investigational drug (30 days)
Lung resection surgery (e.g., lung volume reduction surgery, or lobectomy) within 1 year of Visit 1.
A COPD exacerbation and/or infection of the upper or lower respiratory tract requiring treatment with systemic (oral or parenteral) corticosteroids and/or antibiotics that has not resolved within 30 days of Visit 1
A COPD exacerbation that resulted in hospitalization that has not resolved within 3 months of Visit 1.
Use of nocturnal positive pressure [e.g., continuous positive airway pressure or bi-level positive airway pressure].
A body mass index (BMI) of ≥ 40kg/m².
Subject is a study investigator, sub-investigator, study coordinator, or employee of a participating investigator or immediate family members of the aforementioned.
Any intellectual deficiency including illiteracy, history of substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
Supplemental oxygen, with the following exceptions:
Use at high altitude (> 5000 feet) provided subject does not require a flow rate of > 2 L/minute
Use for exertion provided subject does not require > 2 hours per day of oxygen and does not require a flow rate of > 2L/minute
Use for nocturnal therapy provided subject does not require a flow rate of > 2L/minute

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Union, South Carolina, 29309

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Group 12-Week Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg Twice-daily With Fluticasone Propionate/Salmeterol DISKUS 250/50mcg Twice-daily in Subjects With COPD

The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg, Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg
Keywords: DISKUS, Salmeterol, Fluticasone Propionate, Chronic Obstructive Pulmonary Disease (COPD), Hydroflouroalkane, COPD, HFA MDI
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluticasone Propionate/Salmeterol DISKUS 250/50mcgDrug
treatment drug
Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcgDrug
Also called Fluticasone Propionate/Salmeterol DISKUS 250/50mcg
treatment drug

Study groups in NCT00633217
Study group	Role	What they receive
arm 1	Active comparator	Not described Receives: Drug: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg
arm 2	Experimental	Not described Receives: Drug: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug
The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.
Measured: 2 hours after administration of blinded study drug; Baseline through Week 12

Secondary outcomes (2)

Mean Change From Baseline in AM Pre-dose FEV1
Change from baseline was calculated as the value at Endpoint minus the baseline value. AM pre-dose FEV1, which is assessed using spirometry, is the maximum amount of air you can forcefully exhale in one second prior to taking the morning dose of study drug. Endpoint was defined as the last scheduled observation for AM pre-dose FEV1 during the 12-week treatment period.
Measured: Measurement of FEV1 prior to study drug administration; Baseline through Week 12
Mean Change From Baseline in Peak Expiratory Flow
The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. This is measured by a peak flow meter which is a hand held device. Change from baseline was calculated as the average value over Weeks 1-12 minus the baseline value.
Measured: Baseline through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Feb 2009

First posted11 Mar 2008 (estimated)
Study startMar 2008
Primary completionFeb 2009
Study completionFeb 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00633217
Sponsor's protocol ID: 111117
Status last verified: Oct 2016
First submitted: 19 Feb 2008
Last updated: 8 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Koser A, Westerman J, Sharma S, Emmett A, Crater GD. Safety and efficacy of fluticasone propionate/salmeterol hydrofluoroalkane 134a metered-dose-inhaler compared with fluticasone propionate/salmeterol diskus in patients with chronic obstructive pulmonary disease. Open Respir Med J. 2010 Oct 21;4:86-91. doi: 10.2174/1874306401004010086.
PubMed 21253451

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Group 12-Week Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg Twice-daily With Fluticasone Propionate/Salmeterol DISKUS 250/50mcg Twice-daily in Subjects With COPD
ClinicalTrials.gov ID: NCT00633217
Acronym / sponsor ID: 111117
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: DISKUS, Salmeterol, Fluticasone Propionate, Chronic Obstructive Pulmonary Disease (COPD), Hydroflouroalkane, COPD, HFA MDI
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 11 Mar 2008 (estimated)
Results: Posted 26 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
arm 1	Active comparator	Drug: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg
arm 2	Experimental	Drug: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
Males or females ≥ 40 years of age.
non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal [i.e., >1 year without menses in the absence of hormone replacement therapy]); or,
child-bearing potential, has a negative pregnancy test (urine) at screen, and one of the following applies:
COPD is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences [Celli, 2004].

Key exclusion criteria (26 listed)

A current diagnosis of asthma.
Any clinically significant and uncontrolled disease, including but not limited to the following: neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would affect the efficacy analysis if the disease/condition exacerbated during the study.
A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency. Allergic rhinitis is not exclusionary.
An abnormal and clinically significant chest x-ray or computed tomography (CT) scan not believed to be due to the presence of COPD. A chest x-ray must be taken if the subject has not had one within 6 months of Visit 1.
An abnormal and clinically significant 12-lead electrocardiogram (ECG). For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:

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
Fluticasone Propionate/Salmeterol DISKUS 250/50mcgtreatment drug	Drug	arm 1
Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcgAlso: Fluticasone Propionate/Salmeterol DISKUS 250/50mcgtreatment drug	Drug	arm 2

Primary outcome

Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug
Time frame: 2 hours after administration of blinded study drug; Baseline through Week 12
The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.

2 secondary outcomes

Mean Change From Baseline in AM Pre-dose FEV1
Time frame: Measurement of FEV1 prior to study drug administration; Baseline through Week 12
Mean Change From Baseline in Peak Expiratory Flow
Time frame: Baseline through Week 12

Results and safety

Results posted to the registry on 26 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HFA MDI 230/42 mcg and Matching DISKUS Placebo	121	106
DISKUS 250/50 mcg and Matching HFA MDI Placebo	126	103

Primary outcome: Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug

Time frame: 2 hours after administration of blinded study drug; Baseline through Week 12. Mean (Standard Error). Unit: milliliters (mL)

Measure	HFA MDI 230/42 mcg and Matching DISKUS Placebo n = 116	DISKUS 250/50 mcg and Matching HFA MDI Placebo n = 115
Value	155 (23.4)	150 (21.9)

HFA MDI 230/42 mcg and Matching DISKUS Placebo vs DISKUS 250/50 mcg and Matching HFA MDI Placebo: p = 0.021, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants who had been randomized to study drug. The numbers analyzed do not match Baseline numbers due to missing data for some participants.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HFA MDI 230/42 mcg and Matching DISKUS Placebo	6 of 121 (5%)	27 of 121 (22.3%)	Not reported
DISKUS 250/50 mcg and Matching HFA MDI Placebo	3 of 126 (2.4%)	29 of 126 (23%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21253451Koser A, Westerman J, Sharma S, Emmett A, Crater GD. Safety and efficacy of fluticasone propionate/salmeterol hydrofluoroalkane 134a metered-dose-inhaler compared with fluticasone propionate/salmeterol diskus in patients with chronic obstructive pulmonary disease. Open Respir Med J. 2010 Oct 21;4:86-91. doi: 10.2174/1874306401004010086.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 inclusion and 26 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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.

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 26 Nov 2009). 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?

Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug (time frame: 2 hours after administration of blinded study drug; Baseline through Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00633217, which also lists 1 linked publication.

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 8 Dec 2016.