Pulmonary Disease, Chronic ObstructivePhase 2NCT00706914

Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Once-daily aclidinium/formoterol, Twice-daily formoterol fumarate and Once-daily formoterol fumarate in people with Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 40 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Once-daily aclidinium/formoterol, Twice-daily formoterol fumarate and Once-daily formoterol fumarate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 40 sitesUnited States
Study dates: 30 Jun 2008to 11 Nov 2008
Phase: Phase 2
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Moderate to severe COPD
Smoking history of greater or equal to 10 pack-years
Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
Postbronchodilator FEV1/FVC ratio < 0.70

Who cannot join

History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Eosinophil count of at least 600 cells/mm3
Long term oxygen therapy > 15 hours a day

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Forest Investigative Site
Albany, New York, 12205
Forest Investigative Site
Atlanta, Georgia, 30342
Forest Investigative Site
Austell, Georgia, 30106
Forest Investigative Site
Blue Ridge, Georgia, 30513
Forest Investigative Site
Bowling Green, Kentucky, 42101
Forest Investigative Site
Charlotte, North Carolina, 28207
Forest Investigative Site
Cincinnati, Ohio, 45242
Forest Investigative Site
Columbus, Ohio, 43215
Forest Investigative Site
Dallas, Texas, 75246
Forest Investigative Site
DeLand, Florida, 32720
Forest Investigative Site
East Providence, Rhode Island, 02914
Forest Investigative Site
Florissant, Missouri, 63033
Forest Investigative Site
Fullerton, California, 92835
Forest Investigative Site
Hartford, Connecticut, 06105
Forest Investigative Site
Hazard, Kentucky, 41701
Forest Investigative Site
Lakewood, California, 90712
Forest Investigative Site
McKinney, Texas, 75069
Forest Investigative Site
Medford, Oregon, 97504
Forest Investigative Site
Midvale, Utah, 84047
Forest Investigative Site
Milwaukee, Wisconsin, 53209
Forest Investigative Site
New Britain, Connecticut, 06053
Forest Investigative Site
North Dartmouth, Massachusetts, 02747
Forest Investigative Site
Panama City, Florida, 32405
Forest Investigative Site
Pittsburgh, Pennsylvania, 15213
Forest Investigative Site
Rancho Mirage, California, 92270
Forest Investigative Site
Redlands, California, 92373
Forest Investigative Site
Richmond, Virginia, 23225
Forest Investigative Site
Rochester, Minnesota, 55905
Forest Investigative Site
Saint Charles, Missouri, 63301
Forest Investigative Site
San Diego, California, 92120
Forest Investigative Site
San Jose, California, 95124
Forest Investigative Site
Spartanburg, South Carolina, 29303
Forest Investigative Site
St Louis, Missouri, 63110
Forest Investigative Site
Stockton, California, 95207
Forest Investigative Site
Tamarac, Florida, 33321
Forest Investigative Site
Tampa, Florida, 33603
Forest Investigative Site
Tucson, Arizona, 85715
Forest Investigative Site
Tucson, Arizona, 85741
Forest Investigative Site
Waterbury, Connecticut, 06708
Forest Investigative Site
Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Once-daily aclidinium/formoterol, Twice-daily formoterol fumarate, Placebo to formoterol fumarate, Once-daily formoterol fumarate
Keywords: Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
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.

Once-daily aclidinium/formoterolDrug
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Twice-daily formoterol fumarateDrug
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Placebo to formoterol fumarateDrug
Inhaled placebo to formoterol fumarate once-daily in the evening
Once-daily formoterol fumarateDrug
Inhaled formoterol fumarate 12 μg once-daily in the evening

Study groups in NCT00706914
Study group	Role	What they receive
Once-daily aclidinium/formoterol	Experimental	Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening Receives: Drug: Once-daily aclidinium/formoterol; Drug: Placebo to formoterol fumarate
Morning aclidinium/formoterol plus evening formoterol	Experimental	Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening Receives: Drug: Once-daily aclidinium/formoterol; Drug: Once-daily formoterol fumarate
Formoterol BID	Active comparator	Formoterol fumarate 12 µg twice-daily (BID) Receives: Drug: Twice-daily formoterol fumarate

What is being measured

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

Change From Baseline in Weekly Average Nocturnal Symptom Scores
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
Measured: Week 4 of treatment
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon
Measured: Week 4 of treatment

Timeline

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

30 Jun 200811 Nov 2008

First posted30 Jun 2008 (estimated)
Study start30 Jun 2008
Primary completion11 Nov 2008
Study completion11 Nov 2008

Why it stopped: Actual sample size of 156 was sufficient to estimate the clinical outcomes.

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 Pulmonary Disease, Chronic ObstructiveStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00706914
Sponsor's protocol ID: LAC-MD-24
Status last verified: Apr 2017
First submitted: 26 Jun 2008
Last updated: 15 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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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.
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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily
ClinicalTrials.gov ID: NCT00706914
Acronym / sponsor ID: LAC-MD-24
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Actual sample size of 156 was sufficient to estimate the clinical outcomes.
Enrolment: 156 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 30 Jun 2008 (actual)
Primary completion: 11 Nov 2008 (actual)
Study completion: 11 Nov 2008 (actual)
First posted: 30 Jun 2008 (estimated)
Results: Posted 15 May 2017

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: 3

Arm	Type	Receives
Once-daily aclidinium/formoterol	Experimental	Drug: Once-daily aclidinium/formoterol, Drug: Placebo to formoterol fumarateAclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening
Morning aclidinium/formoterol plus evening formoterol	Experimental	Drug: Once-daily aclidinium/formoterol, Drug: Once-daily formoterol fumarateAclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening
Formoterol BID	Active comparator	Drug: Twice-daily formoterol fumarateFormoterol fumarate 12 µg twice-daily (BID)

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Moderate to severe COPD
Smoking history of greater or equal to 10 pack-years
Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
Postbronchodilator FEV1/FVC ratio < 0.70

Key exclusion criteria (5 listed)

History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Eosinophil count of at least 600 cells/mm3
Long term oxygen therapy > 15 hours a 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
Once-daily aclidinium/formoterolInhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning	Drug	Morning aclidinium/formoterol plus evening formoterol, Once-daily aclidinium/formoterol
Twice-daily formoterol fumarateInhaled formoterol fumarate 12 µg twice-daily (BID)	Drug	Formoterol BID
Placebo to formoterol fumarateInhaled placebo to formoterol fumarate once-daily in the evening	Drug	Once-daily aclidinium/formoterol
Once-daily formoterol fumarateInhaled formoterol fumarate 12 μg once-daily in the evening	Drug	Morning aclidinium/formoterol plus evening formoterol

Primary outcome

Change From Baseline in Weekly Average Nocturnal Symptom Scores
Time frame: Week 4 of treatment
Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all
Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
Time frame: Week 4 of treatment
Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon

Results and safety

Results posted to the registry on 15 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Once-daily Aclidinium/Formoterol	63	57
Morning Aclidinium/Formoterol Plus Evening Formoterol	62	58
Formoterol BID	31	30

Primary outcome: Change From Baseline in Weekly Average Nocturnal Symptom Scores

Time frame: Week 4 of treatment. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	Once-daily Aclidinium/Formoterol n = 62	Morning Aclidinium/Formoterol Plus Evening Formoterol n = 61	Formoterol BID n = 31
Value	-0.15 (-0.33 to 0.04)	-0.09 (-0.26 to 0.08)	-0.35 (-0.59 to -0.12)

Population analysed: Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.

Primary outcome: Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores

Time frame: Week 4 of treatment. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	Once-daily Aclidinium/Formoterol n = 62	Morning Aclidinium/Formoterol Plus Evening Formoterol n = 61	Formoterol BID n = 31
Value	-0.17 (-0.34 to -0.01)	0.13 (-0.07 to 0.32)	-0.00 (-0.20 to 0.20)

Adverse events

Time frame: 29 ± 2 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Once-daily Aclidinium/Formoterol	1 of 63 (1.6%)	0 of 63 (0%)	Not reported
Morning Aclidinium/Formoterol Plus Evening Formoterol	1 of 62 (1.6%)	0 of 62 (0%)	Not reported
Formoterol BID	0 of 31 (0%)	2 of 31 (6.5%)	Not reported

Limitations and caveats (from the sponsor): Due to early termination of the study, the actual sample size is different from the study design (200 patients) Actual sample size was 156, but because this was an exploratory study, this was considered sufficient to estimate the clinical outcomes

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
lac-md-24-synopsisLink provided by the sponsor.

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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.

Esther Garcia, MD study director

AstraZeneca

40 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 May 2017). 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 Weekly Average Nocturnal Symptom Scores (time frame: Week 4 of treatment). 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?

On the ClinicalTrials.gov record for NCT00706914.

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 15 May 2017.