AzTrials
AzTrials

AsthmaPhase 2NCT00583947

A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

A Phase 2 study testing arformoterol and levalbuterol in people with Asthma, run by Sumitomo Pharma America, Inc. at 14 sites in United States.

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

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Asthma
What is being tested?
arformoterol and levalbuterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
14 sitesUnited States
Study dates
Jan 2008to Dec 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 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male and Female
  • Between Age 2 and 11, inclusive, at the time of consent
  • Weight equal to or greater than 15 Kg
  • History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.

Who cannot join

  • Female subject who is pregnant or lactating.
  • Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
  • Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • Subject with a history of cancer.
  • Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
  • Subject with a history of cigarette smoking or use of any tobacco products.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Burke, Virginia, 22015

  • Study site

    Dallas, Texas, 75230

  • Study site

    Medford, Oregon, 97504

  • Study site

    Normal, Illinois, 61761

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Orange, California, 92868

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Portland, Oregon, 97213

  • Study site

    Richmond, Virginia, 23229

  • Study site

    Savannah, Georgia, 31406

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Upland, Pennsylvania, 19013

Other trials in United States

About this study

Official title: A Cumulative Dose Safety and Tolerability Crossover Study of Arformoterol Tartrate Inhalation Solution and Levalbuterol Hydrochloride Inhalation Solution in Pediatric Subjects (Aged 2 to 11 Years of Age) With Asthma

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Read the detailed description

A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions
Asthma
Being tested
arformoterol, levalbuterol
Keywords
Asthma, Respiratory Tract Diseases
Medical subject headings
Asthma, Respiratory Tract Diseases

What participants receive

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

  • arformoterolDrug

    Also called Brovana

    Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

  • levalbuterolDrug

    Also called Xopenex

    Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Study groups in NCT00583947
Study groupRoleWhat they receive
ARF/LEVOtherCross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
Receives: Drug: arformoterol; Drug: levalbuterol
LEV/ARFOtherCross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
Receives: Drug: arformoterol; Drug: levalbuterol

What is being measured

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

  1. Mean Heart Rate

    Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

    Measured: predose, various timeframes up to 5 hours post last dose

  2. Change From Predose in Mean Heart Rate

    Heart rate measured at various timepoints minus the heart rate at predose.

    Measured: predose, various timeframes up to 5 hours post last dose

  3. Mean Systolic Blood Pressure

    Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

    Measured: predose, various timeframes up to 5 hours post last dose

  4. Change From Predose in Mean Systolic Blood Pressure

    Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose

    Measured: predose, various timeframes up to 5 hours post last dose

  5. Mean Diastolic Blood Pressure

    Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

    Measured: predose, various timeframes up to 5 hours post last dose

  6. Change From Predose in Mean Diastolic Blood Pressure

    Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure

    Measured: predose, various timeframes up to 5 hours post last dose

  7. Mean Serum Potassium Levels

    Measured: Predose, 2 hours and 6 hours postdose 1

  8. Change From Predose in Mean Serum Potassium

    Change in mean serum potassium at the specified timepoint minus the predose value.

    Measured: predose, 2 and 6 hours post dose

  9. Mean Serum Glucose Values

    Measured: Predose, 2 and 6 hours post dose 1

  10. Change From Predose in Mean Serum Glucose

    Change in mean serum glucose at the specified timepoint minus the predose value.

    Measured: predose, 2 and 6 hours post dose

Secondary outcomes (5)

  1. Mean Forced Expiratory Volume in One Second(FEV1)

    Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.

    Measured: predose, various postdose times

  2. Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)

    Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.

    Measured: predose, various postdose timepoints

  3. Mean Peak Expiratory Flow Rate (PEFR)

    PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.

    Measured: predose, various postdose times

  4. Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)

    PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.

    Measured: predose, various postdose times

  5. Plasma Concentration of (R,R) Formoterol

    If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.

    Measured: predose, various postdose times

Timeline

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

  1. First posted2 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00583947
Sponsor's protocol ID
091-029
Status last verified
Jan 2012
First submitted
21 Dec 2007
Last updated
22 Feb 2012
Data monitoring committee
No

Publications

  • Hinkle J, Hinson J, Kerwin E, Goodwin E, Sciarappa K, Curry L, Hanrahan JP. A cumulative dose, safety and tolerability study of arformoterol in pediatric subjects with stable asthma. Pediatr Pulmonol. 2011 Aug;46(8):761-9. doi: 10.1002/ppul.21446. Epub 2011 May 16.

    PubMed 21584948

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing arformoterol and levalbuterol in people with Asthma, run by Sumitomo Pharma America, Inc. at 14 sites 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 4 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: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 8 Feb 2010). 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 Heart Rate (time frame: predose, various timeframes up to 5 hours post last dose). The study lists 10 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 NCT00583947, 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 22 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in