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AsthmaPhase 2NCT00635882

Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)

A Phase 2 study testing mometasone furoate/formoterol 100/10 mcg, mometasone furoate/formoterol 200/10 mcg and mometasone furoate/formoterol 400/10 mcg in people with Asthma and Airway Inflammation, run by Organon and Co.

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

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma, Airway Inflammation
What is being tested?
mometasone furoate/formoterol 100/10 mcg, mometasone furoate/formoterol 200/10 mcg and mometasone furoate/formoterol 400/10 mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
No sites listed yet
Study dates
Feb 2008to Jun 2009
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • To document asthma diagnosis, historical reversibility defined as an increase in absolute forced expiratory volume (in liters) in 1 second (FEV1) of >= 12% and >= 200 mL must have been performed within 12 months of Screening. For subjects without historical reversibility, one of the following methods can be used at the Screening Visit or at any time before the Baseline Visit:
  • Demonstration of an increase in absolute FEV1 of at least 12% and a volume increase of at least 200 mL within 15-20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose 360 to 400 mcg) or of nebulized short-acting beta agonist (SABA) (2.5 mg), if confirmed as standard office practice, OR
  • Demonstration of a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the mean highest and lowest morning prebronchodilator PEF over at least 1 week, OR
  • Demonstration of a diurnal variation PEF of more than 20% based on the difference between the prebronchodilator (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period. {The calculation formula: Diurnal PEF Variation = Absolute [(highest of 3 readings, PM Post-bronchodilator (BD) PEF from prior evening) - (highest of 3 readings, AM Pre-BD from morning value)]/[(highest PM Post-BD + highest AM Pre-BD)/2] * 100}
  • At Screening and Baseline Visits, a subject must have persistent allergic asthma with an FEV1 >65% predicted.
  • A subject must be allergic to at least one common allergen (grasses, trees, weeds, house dust mites, molds, dog and cat) as demonstrated by clinical symptoms when exposed to the allergen(s), and by skin prick testing or a radioallergosorbent (RAST) class >1 (excluding modified RAST procedure [mRAST]) within 2 years of inclusion in the study.
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  • If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, the subject and/or parent/guardian) must agree to discontinue prescribed inhaled corticosteroid (ICS), anticholinergics, leukotriene receptor inhibitors, and long-acting beta-2 agonists at the Screening Visit as per required washouts, and be transferred to treatment with SABA for relief for 2 weeks before the Baseline/Randomization Visit.
  • Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.
  • An electrocardiogram (ECG) performed at the Screening Visit or within 30 days prior to Screening Visit must be clinically acceptable to the investigator and have a QTc interval <440 milliseconds for males and <450 msec for females.
  • At Screening or any time prior to Baseline, a subject must have an eNO level of >30 parts per billion (ppb) at a flow rate of 50 mL/second.
  • At Screening or any time before Baseline, a subject must have a sputum eosinophil count >3% of total cell count.
  • Willingness to give written informed consent and ability to adhere to dose and visit schedules. A subject 12 to 17 years of age must also provide written assent.
  • A nonpregnant female subject of childbearing potential (with a negative serum pregnancy test at Screening) must use a medically acceptable, adequate form of birth control. If not currently sexually active she must agree to use a double-barrier method if she becomes sexually active during the study.

Who cannot join

  • Use of systemic glucocorticosteroids within 3 months before Screening.
  • Upper or lower respiratory tract infection within 4 weeks before Screening.
  • Decrease in absolute FEV1 >20% between Screening and Baseline Visits.
  • Requirement for > 8 inhalations per day of SABA MDI, or 2 or more nebulized treatments of 2.5 mg SABA, on any 2 consecutive days between the Screening and Baseline Visits.
  • A decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days before Baseline. At Visit 1, the Run-in Period stability limit for PEF will be established based on the subject's personal best. If the subject does not have a historical personal best, the historical PEF measurement will be the PEF predicted based on the subject's sex, age, and height. PEF value to be multiplied by 0.70 to determine stability limit.
  • A clinical asthma exacerbation defined as a clinical deterioration of asthma that results in emergency treatment, hospitalization for asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids but allowing SABA), as per investigator, between Screening and Baseline Visits.
  • Inability to induce sputum after 1 or 2 trys.

About this study

Official title: A 2-Week Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Anti-Inflammatory Effects of Low, Medium, and High Dose Mometasone Furoate/Formoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adults and Adolescents With Persistent Allergic Asthma

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.

Read the detailed description

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period.

A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003.

Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS).

Being tested
mometasone furoate/formoterol 100/10 mcg, mometasone furoate/formoterol 200/10 mcg, mometasone furoate/formoterol 400/10 mcg, MF DPI 200 mcg, MF MDI 200 mcg
Keywords
mometasone, formoterol
Medical subject headings
Asthma

What participants receive

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

  • mometasone furoate/formoterol 100/10 mcgDrug

    Also called MF/F (SCH 418131)

    mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days

  • mometasone furoate/formoterol 200/10 mcgDrug

    Also called MF/F 200/10 (SCH 418131)

    mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days

  • mometasone furoate/formoterol 400/10 mcgDrug

    Also called MF/F 400/10 (SCH 418131)

    mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days

  • MF DPI 200 mcgDrug

    Also called mometasone furoate (SCH 32088)

    MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days

  • MF MDI 200 mcgDrug

    Also called mometasone furoate (SCH 32088)

    MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days

  • PlaceboDrug

    MF/F MDI placebo twice daily (BID) (2 inhalations)

Study groups in NCT00635882
Study groupRoleWhat they receive
MF/F MDI 100/10 mcgExperimentalNot described
Receives: Drug: mometasone furoate/formoterol 100/10 mcg
MF/F MDI 200/10 mcgExperimentalNot described
Receives: Drug: mometasone furoate/formoterol 200/10 mcg
MF/F MDI 400/10 mcgExperimentalNot described
Receives: Drug: mometasone furoate/formoterol 400/10 mcg
MF DPI 200 mcgExperimentalNot described
Receives: Drug: MF DPI 200 mcg
MF MDI 200 mcgExperimentalNot described
Receives: Drug: MF MDI 200 mcg
PlaceboExperimentalNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)

    Measured: Baseline to Day 14

Secondary outcomes (7)

  1. Mean Percent Change From Baseline to Day 7 in eNO Ppb

    Measured: Baseline to Day 7

  2. Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)

    Measured: Baseline to Day 14

  3. Mean Change From Baseline to Day 15 of Mannitol Challenge

    Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).

    Measured: Baseline to Day 15

  4. Change From Baseline in AM Total Asthma Symptom Score at Days 2-15

    Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.

    Measured: Baseline and Days 2-15

  5. Change From Baseline in PM Total Asthma Symptom Score at Days 1-15

    Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.

    Measured: Baseline and Days 1-15

  6. Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15

    Measured: Baseline and Days 2-15

  7. Change From Baseline in PM PEF at Days 1-15

    Measured: Baseline and Days 1-15

Timeline

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

  1. First posted14 Mar 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00635882
Sponsor's protocol ID
P05122
Status last verified
Feb 2022
First submitted
21 Jan 2008
Last updated
14 May 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • Nolte H, Pavord I, Backer V, Spector S, Shekar T, Gates D, Nair P, Hargreave F. Dose-dependent anti-inflammatory effect of inhaled mometasone furoate/formoterol in subjects with asthma. Respir Med. 2013 May;107(5):656-64. doi: 10.1016/j.rmed.2013.02.010. Epub 2013 Mar 13.

    PubMed 23490226

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mometasone furoate/formoterol 100/10 mcg, mometasone furoate/formoterol 200/10 mcg and mometasone furoate/formoterol 400/10 mcg in people with Asthma and Airway Inflammation, run by Organon and Co.

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 13 inclusion and 7 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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 9 Feb 2011). 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 Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) (time frame: Baseline to Day 14). 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 NCT00635882, 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 14 May 2024.

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