AsthmaPhase 2NCT01641081

Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

A Phase 2 study testing Formoterol Fumarate in the Pressair DPI, Low Dose, Formoterol Fumarate in the Pressair DPI, High Dose and Foradil Aerolizer, Low Dose in people with Asthma, run by AstraZeneca at 29 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

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Formoterol Fumarate in the Pressair DPI, Low Dose, Formoterol Fumarate in the Pressair DPI, High Dose and Foradil Aerolizer, Low Dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 174 participants
Where: 29 sitesUnited States
Study dates: Jun 2012to Feb 2013
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Inclusions:

Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure).
Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30 days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1.
Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of predicted for age, height, and gender using NHANES III (NHANES 2010) when bronchodilator medications have been withheld the appropriate length of time per the List of Concomitant Medications (Appendix III)
Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after the administration of 360 µg of albuterol.
Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the qualifying FEV1 at Visit 1

Exclusions:

Patients with any clinically significant respiratory conditions other than mild to moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung disease
Patients with a severe asthma exacerbation requiring hospitalization in the previous 12 months
Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at least 6 hours prior to visit

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Forest Investigative Site 1333
Baltimore, Maryland, 21236
Forest Investigative Site 1609
Bellevue, Nebraska, 68123
Forest Investigative Site 1134
Canton, Ohio, 44718
Forest Investigative Site 1996
Centennial, Colorado, 80112
Forest Investigative Site 2025
Charleston, South Carolina, 29407
Forest Investigative Site 1806
Cincinnati, Ohio, 45231
Forest Investigative Site 1137
Colorado Springs, Colorado, 80907
Forest Investigative Site 1155
Dallas, Texas, 75231
Forest Investigative Site 1998
Denver, Colorado, 80230
Forest Investigative Site 1332
El Paso, Texas, 79903
Forest Investigative Site 2066
Encinitas, California, 92024
Forest Investigative Site 1624
Los Angeles, California, 90025
Forest Investigative Site 1536
Louisville, Kentucky, 40215
Forest Investigative Site 1997
Madison, Wisconsin, 53792
Forest Investigative Site 2043
Medford, Oregon, 97504
Forest Investigative Site 2041
Minneapolis, Minnesota, 55402
Forest Investigative Site 1995
Mission Viejo, California, 92691
Forest Investigative Site 1370
New Braunfels, Texas, 78130
Forest Investigative Site 1431
North Dartmouth, Massachusetts, 02747
Forest Investigative Site 1176
Oklahoma City, Oklahoma, 73120
Forest Investigative Site 909
Phoenix, Arizona, 85006
Forest Investigative Site 1580
Portland, Oregon, 97202
Forest Investigative Site 1153
Raleigh, North Carolina, 27607
Forest Investigative Site 1699
San Antonio, Texas, 78229
Forest Investigative Site 1347
San Jose, California, 95117
Forest Investigative Site 2011
Seattle, Washington, 98115
Forest Investigative Site 1999
Skillman, New Jersey, 08558
Forest Investigative Site 1599
St Louis, Missouri, 63141
Forest Investigative Site 2047
Tampa, Florida, 33613

Other trials in United States

About this study

Official title: Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.

This study will include a screening visit followed by a 4 month treatment period.

Conditions: Asthma
Being tested: Formoterol Fumarate in the Pressair DPI, Low Dose, Formoterol Fumarate in the Pressair DPI, High Dose, Foradil Aerolizer, Low Dose, Foradil Aerolizer, High Dose, Placebo
Medical subject headings: Asthma

What participants receive

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

Formoterol Fumarate in the Pressair DPI, Low DoseDrug
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI, High DoseDrug
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Foradil Aerolizer, Low DoseDrug
Also called Formoterol
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Foradil Aerolizer, High DoseDrug
Also called Formoterol
Foradil Aerolizer 24 micrograms, twice per day for 14 days
PlaceboDrug
Placebo in the Pressair for 14 days

Study groups in NCT01641081
Study group	Role	What they receive
Experimental 1	Experimental	Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose Receives: Drug: Formoterol Fumarate in the Pressair DPI, Low Dose
Experimental 2	Experimental	Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose Receives: Drug: Formoterol Fumarate in the Pressair DPI, High Dose
Active Comparator 1	Active comparator	Foradil Aerolizer, Low Dose Receives: Drug: Foradil Aerolizer, Low Dose
Active Comparator 2	Active comparator	Foradil Aerolizer, High Dose Receives: Drug: Foradil Aerolizer, High Dose
Placebo	Placebo comparator	Dose matched placebo Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Measured: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment

Secondary outcomes (1)

Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Measured: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment

Timeline

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

Jun 2012Feb 2013

First posted16 Jul 2012 (estimated)
Study startJun 2012
Primary completionFeb 2013
Study completionFeb 2013

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 AsthmaStudies 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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01641081
Sponsor's protocol ID: LAC-MD-21
Status last verified: Jan 2017
First submitted: 12 Jul 2012
Last updated: 28 Feb 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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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.
ClinicalTrials.gov ID: NCT01641081
Acronym / sponsor ID: LAC-MD-21
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 16 Jul 2012 (estimated)
Results: Posted 22 Dec 2016

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 Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.

This study will include a screening visit followed by a 4 month treatment period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Experimental 1	Experimental	Drug: Formoterol Fumarate in the Pressair DPI, Low DoseFormoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
Experimental 2	Experimental	Drug: Formoterol Fumarate in the Pressair DPI, High DoseFormoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
Active Comparator 1	Active comparator	Drug: Foradil Aerolizer, Low DoseForadil Aerolizer, Low Dose
Active Comparator 2	Active comparator	Drug: Foradil Aerolizer, High DoseForadil Aerolizer, High Dose
Placebo	Placebo comparator	Drug: PlaceboDose matched placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Formoterol Fumarate in the Pressair DPI, Low DoseFormoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days	Drug	Experimental 1
Formoterol Fumarate in the Pressair DPI, High DoseFormoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days	Drug	Experimental 2
Foradil Aerolizer, Low DoseAlso: FormoterolForadil Aerolizer 12 micrograms, twice a day for 14 days	Drug	Active Comparator 1
Foradil Aerolizer, High DoseAlso: FormoterolForadil Aerolizer 24 micrograms, twice per day for 14 days	Drug	Active Comparator 2
PlaceboPlacebo in the Pressair for 14 days	Drug	Placebo

Primary outcome

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
Time frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals

1 secondary outcome

Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
Time frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment

Results and safety

Results posted to the registry on 22 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	18	17
Sequence 2	18	18
Sequence 3	15	15
Sequence 4	22	22
Sequence 5	17	16
Sequence 6	19	19
Sequence 7	19	18
Sequence 8	17	14
Sequence 9	15	15
Sequence 10	14	14

Primary outcome: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)

Time frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment. Least squares mean (Standard Error). Unit: Liters

Measure	Foradil 24 μg n = 155	Foradil 12 μg n = 151	Formoterol 12 μg n = 155	Formoterol 6 μg n = 159	Placebo n = 154
Value	0.3196 (0.0382)	0.3076 (0.0382)	0.2795 (0.0382)	0.2726 (0.0381)	0.0552 (0.0382)

Foradil 24 μg vs Placebo: Least squares mean difference: 0.2644 (95% CI 0.2353 to 0.2934), p <0.0001, Mixed Models Analysis
Foradil 12 μg vs Placebo: Least squares mean difference: 0.2524 (95% CI 0.2218 to 0.2830), p <0.0001, Mixed Models Analysis
Formoterol 12 μg vs Placebo: Least squares mean difference: 0.2242 (95% CI 0.1941 to 0.2544), p <0.0001, Mixed Models Analysis

Population analysed: Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 14±1 of the final treatment period (Period 5). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Foradil 24 μg	0 of 167 (0%)	10 of 167 (6%)	Not reported
Foradil 12 μg	2 of 163 (1.2%)	2 of 163 (1.2%)	Not reported
Formoterol 12 μg	0 of 164 (0%)	2 of 164 (1.2%)	Not reported
Formoterol 6 μg	0 of 166 (0%)	1 of 166 (0.6%)	Not reported
Placebo	0 of 165 (0%)	0 of 165 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR SynopsisLink provided by the sponsor.

Related trials for Asthma

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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

29 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?

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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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. 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 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 22 Dec 2016). 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 Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14) (time frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment). 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 NCT01641081.

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 28 Feb 2017.