Chronic Obstructive Pulmonary DiseasePhase 3NCT00891462

Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 112 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Aclidinium bromide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 561 participants
Where: 112 sitesin 2 countries
Study dates: Apr 2009to Nov 2009
Phase: Phase 3
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

A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
Current or former cigarette smokers

Who cannot join

Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
History or presence of asthma verified from medical records
Chronic use of oxygen therapy greater than or equal to 15 hours per day
Patient with uncontrolled infection due to HIV and/or active hepatitis
Patients with a history of hypersensitivity reaction to inhaled anticholinergics
Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Trial locations and contacts

112 sites in 2 countries.

Country

City, postcode or hospital

112 sites in 2 countries

United States104 sites

Forest Investigative Site
Anaheim, California, 92801
Forest Investigative Site
Asheville, North Carolina, 28801
Forest Investigative Site
Austell, Georgia, 30106
Forest Investigative Site
Baltimore, Maryland, 21201
Forest Investigative Site
Baltimore, Maryland, 21224
Forest Investigative Site
Bangor, Maine, 04401
Forest Investigative Site
Bellingham, Washington, 98225
Forest Investigative Site
Berlin, New Jersey, 08009
Forest Investigative Site
Bethlehem, Pennsylvania, 18020
Forest Investigative Site
Billings, Montana, 59102
Forest Investigative Site
Birmingham, Alabama, 35209
Forest Investigative Site
Blue Ridge, Georgia, 30513
Forest Investigative Site
Brandon, Florida, 33511
Forest Investigative Site
Brooklyn, New York, 11234
Forest Investigative Site
Buffalo, New York, 14215
Forest Investigative Site
Butte, Montana, 59701
Forest Investigative Site
Canton, Ohio, 44718
Forest Investigative Site
Charleston, South Carolina, 29406
Forest Investigative Site
Charlotte, North Carolina, 28207
Forest Investigative Site
Cincinnati, Ohio, 45227
Forest Investigative Site
Cincinnati, Ohio, 45231
Forest Investigative Site
Cincinnati, Ohio, 45242
Forest Investigative Site
Clearwater, Florida, 33765
Forest Investigative Site
Colorado Springs, Colorado, 80907
Forest Investigative Site
Columbus, Ohio, 43215
Forest Investigative Site
Crescent Springs, Kentucky, 41017
Forest Investigative Site
Dallas, Texas, 75231
Forest Investigative Site
Dallas, Texas, 75246
Forest Investigative Site
DeLand, Florida, 32720
Forest Investigative Site
Denver, Colorado, 80206
Forest Investigative Site
Duluth, Georgia, 30096
Forest Investigative Site
East Providence, Rhode Island, 02914
Forest Investigative Site
Edina, Minnesota, 55435
Forest Investigative Site
Encinitas, California, 92024
Forest Investigative Site
Erie, Pennsylvania, 16506
Forest Investigative Site
Florissant, Missouri, 63033
Forest Investigative Site
Fort Lauderdale, Florida, 33316
Forest Investigative Site
Fort Worth, Texas, 76104
Forest Investigative Site
Fresno, California, 93726
Forest Investigative Site
Fullerton, California, 92835
Forest Investigative Site
Great Neck, New York, 11023
Forest Investigative Site
Greenville, South Carolina, 29615
Forest Investigative Site
Greer, South Carolina, 29651
Forest Investigative Site
Hagerstown, Maryland, 21740
Forest Investigative Site
Hershey, Pennsylvania, 17033
Forest Investigative Site
Houston, Texas, 77024
Forest Investigative Site
Ithaca, New York, 14580
Forest Investigative Site
Jasper, Alabama, 35501
Forest Investigative Site
Johnston, Rhode Island, 02919
Forest Investigative Site
Lafayette, Louisiana, 70503
Forest Investigative Site
Lakewood, California, 90712
Forest Investigative Site
Lexington, Kentucky, 40504
Forest Investigative Site
Livonia, Michigan, 48152
Forest Investigative Site
Marietta, Georgia, 30060
Forest Investigative Site
Medford, Oregon, 97504
Forest Investigative Site
Melbourne, Florida, 32901
Forest Investigative Site
Melbourne, Florida, 32935
Forest Investigative Site
Mesa, Arizona, 85210
Forest Investigative Site
Midvale, Utah, 84047
Forest Investigative Site
Milwaukee, Wisconsin, 53209
Forest Investigative Site
Minneapolis, Minnesota, 55402
Forest Investigative Site
Minneapolis, Minnesota, 55407
Forest Investigative Site
Mobile, Alabama, 18020
Forest Investigative Site
Nashville, Tennessee, 37232-2650
Forest Investigative Site
New Hyde Park, New York, 11040
Forest Investigative Site
New York, New York, 10004
Forest Investigative Site
New York, New York, 10016
Forest Investigative Site
North Dartmouth, Massachusetts, 02747
Forest Investigative Site
Oklahoma City, Oklahoma, 73120
Forest Investigative Site
Orange, California, 92868
Forest Investigative Site
Ormond Beach, Florida, 32174
Forest Investigative Site
Palo Alto, California, 94304
Forest Investigative Site
Panama City, Florida, 32405
Forest Investigative Site
Papillion, Nebraska, 68046
Forest Investigative Site
Pensacola, Florida, 32504
Forest Investigative Site
Phoenix, Arizona, 85006
Forest Investigative Site
Phoenix, Arizona, 85023
Forest Investigative Site
Pittsburgh, Pennsylvania, 15243
Forest Investigative Site
Portland, Oregon, 97213
Forest Investigative Site
Raleigh, North Carolina, 27607
Forest Investigative Site
Rancho Mirage, California, 92270
Forest Investigative Site
Richmond, Virginia, 23225
Forest Investigative Site
Richmond, Virginia, 23249
Forest Investigative Site
River Forest, Illinois, 60305
Forest Investigative Site
Sacramento, California, 95831
Forest Investigative Site
Saint Charles, Missouri, 63301
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
San Diego, California, 92103-8415
Forest Investigative Site
San Diego, California, 92120
Forest Investigative Site
Skokie, Illinois, 60076
Forest Investigative Site
South Bend, Indiana, 46617
Forest Investigative Site
Spartanburg, South Carolina, 29303
Forest Investigative Site
Spokane, Washington, 99204
Forest Investigative Site
Summit, New Jersey, 07901
Forest Investigative Site
Tacoma, Washington, 98405
Forest Investigative Site
Tamarac, Florida, 33321
Forest Investigative Site
Tampa, Florida, 33603
Forest Investigative Site
Tampa, Florida, 33613
Forest Investigative Site
Toledo, Ohio, 43606
Forest Investigative Site
Tyler, Texas, 75708
Forest Investigative Site
Upland, Pennsylvania, 19013
Forest Investigative Site
Waco, Texas, 76712
Forest Investigative Site
Waterbury, Connecticut, 06708
Forest Investigative Site
Wheat Ridge, Colorado, 80033

Other trials in United States

Canada8 sites

Forest Investigative Site
Edmonton, T5J 3S9
Forest Investigative Site
Hamilton, L8N 4A6
Forest Investigative Site
Kelowna, V1Y 8E7
Forest Investigative Site
Niagara Falls, L2G 1J4
Forest Investigative Site
Sainte-Foy, G1V 4G5
Forest Investigative Site
Saskatoon, Saskatchewan, S7N 0W8
Forest Investigative Site
Toronto, M5g 1N8
Forest Investigative Site
Toronto, M6H 3M2

Other trials in Canada

About this study

Official title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Aclidinium bromide, Placebo
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema

What participants receive

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

Aclidinium bromideDrug
Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
Aclidinium bromideDrug
Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
PlaceboDrug
Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Study groups in NCT00891462
Study group	Role	What they receive
1	Experimental	Aclidinium bromide dose, inhaled, for 12 weeks of treatment Receives: Drug: Aclidinium bromide
2	Experimental	Aclidinium bromide dose, inhaled, for 12 weeks of treatment Receives: Drug: Aclidinium bromide
3	Placebo comparator	Inhaled placebo for 12 weeks Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Measured: Change from Baseline to 12 weeks

Secondary outcomes (1)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)
Measured: Change from Baseline to 12 weeks

Timeline

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

Apr 2009Nov 2009

First posted1 May 2009 (estimated)
Study startApr 2009
Primary completionNov 2009
Study completionNov 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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 561 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00891462
Sponsor's protocol ID: LAS-MD-33
Other IDs: ACCORD COPD I
Status last verified: Nov 2016
First submitted: 30 Apr 2009
Last updated: 6 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
PubMed 28074135
Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.
PubMed 22320148

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?

See locations

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00891462
Acronym / sponsor ID: LAS-MD-33
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 561 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 1 May 2009 (estimated)
Results: Posted 13 Sep 2012

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Aclidinium bromideAclidinium bromide dose, inhaled, for 12 weeks of treatment
2	Experimental	Drug: Aclidinium bromideAclidinium bromide dose, inhaled, for 12 weeks of treatment
3	Placebo comparator	Drug: PlaceboInhaled placebo for 12 weeks

Who may qualify

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

Key inclusion criteria (2 listed)

A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
Current or former cigarette smokers

Key exclusion criteria (8 listed)

Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
History or presence of asthma verified from medical records
Chronic use of oxygen therapy greater than or equal to 15 hours per day

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
Aclidinium bromideAclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment	Drug	1
Aclidinium bromideAclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment	Drug	2
PlaceboDose-matched placebo, oral inhalation twice per day for 12 weeks of treatment	Drug	3

Primary outcome

Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Change from Baseline to 12 weeks
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

1 secondary outcome

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Change from Baseline to 12 weeks

Results and safety

Results posted to the registry on 13 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	186	149
Aclidinium Bromide, 200µg	185	152
Aclidinium Bromide, 400µg	190	166

Primary outcome: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Change from Baseline to 12 weeks. Least squares mean (Standard Error). Unit: L

Measure	Placebo n = 185	Aclidinium Bromide, 200µg n = 184	Aclidinium Bromide, 400µg n = 190
Value	-0.025 (0.015)	0.062 (0.015)	0.099 (0.015)

Placebo vs Aclidinium Bromide, 200µg: Least Squares Mean Difference: 0.086 (95% CI 0.05 to 0.13), p <0.0001, ANCOVA
Placebo vs Aclidinium Bromide, 400µg: Least Squares Mean Difference: 0.124 (95% CI 0.08 to 0.16), p <0.0001, ANCOVA

Population analysed: Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events reporting occurred from April 28th, 2009 to December 3rd, 2009 at 99 study sites.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 186 (2.2%)	23 of 186 (12.4%)	Not reported
Aclidinium Bromide, 200µg	8 of 184 (4.3%)	17 of 184 (9.2%)	Not reported
Aclidinium Bromide, 400µg	6 of 190 (3.2%)	14 of 190 (7.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28074135McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
Derived from this study: PubMed 22320148Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

Esther Garcia, MD study director

AstraZeneca

112 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 112 sites in 2 countries.

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 2 inclusion and 8 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 13 Sep 2012). 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?

Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (time frame: Change from Baseline to 12 weeks). 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 NCT00891462, which also lists 2 linked publications.

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 Jan 2017.