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AsthmaPhase 3NCT00817817

A Study to Determine the Efficacy and Safety of Two Mometasone Dry Powder Inhalers in the Treatment of Asthma (Study P02524)

A Phase 3 study testing MF in people with Asthma, 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
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Trial summary

This is an open-label, comparative, randomized, parallel, multicenter study in asthmatics to determine whether the administration of dry powder inhaled mometasone furoate (MF) 400 μg in a monodose capsule device would be comparable to administration of powder inhaled MF 400 μg in a multidose device. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
MF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
No sites listed yet
Study dates
1 Oct 2002to 1 May 2003
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • Must be >=18 years of age, of either gender \& of any race.
  • Must have had a diagnosis of asthma for at least 6 months, characterized by recurrent episode of wheezing, breathlessness, chest tightness \& coughing.
  • Baseline FEV1 must be >=55% and <=85% of predicted at the Screening Visit, when all restricted medications have been withheld for the specified intervals.
  • Must demonstrate evidence of an increase in absolute FEV1 of >=12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening Visit or documented in the patients chart reversibility up to 1 year previous to inclusion.
  • Must be free of any clinically significant disease (other than asthma), that would interfere with study evaluations.
  • Must be willing to give written informed consent and be able to adhere to dose \& visit schedules.
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  • Must agree to inform their own usual treating physician about their participation in the study.
  • Non-pregnant women of childbearing potential must be using a medically acceptable, adequate form of birth control. This includes: 1) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); 2) medically prescribed IUD; 3) condom in combination with a spermicide; 4) Monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with a spermicide), \& must agree to continue its use for the duration of the study. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least 1 year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test obtained at screening, prior to initiation of treatment, \& at the end of the trial, which must be negative.
  • Subjects who did not use the following medication prior to inclusion:
  • Beta 2 agonist short-acting (inhaled, oral)(12 Hours)
  • Beta 2 agonist long-acting (inhaled)(48 Hours)
  • Ipratropium bromide (12 hours)
  • Cromolyn sodium, nedocromil (7 days)
  • Astemizole (3 months)
  • Cetotifeno (3 months)
  • Another investigational drug (1 month)
  • Theophyline (2 weeks)
  • Antihistamines (7 days)
  • Anticholinergics (7 days)
  • Leukotriene modifiers (2 weeks)
  • Oral decongestant long-acting (72 hours)
  • Oral decongestant short-acting (24 hours)
  • Oral corticosteroids (1 month)
  • Injected corticosteroids (3 months)
  • Inhaled corticosteroids (24 hours)
  • Baseline portable Peak Expiratory Flow at the Screening Visit must be >50% of predicted. The best value out of 3 must be considered.

Who cannot join

  • Women who are pregnant, breast-feeding, or are pre-menarcheal.
  • Have used any investigational drug within the last 30 days or who have ever been treated with any investigational antibody for asthma or rhinitis.
  • Are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy.
  • No subject participating in this study may participate in this same study at another investigational site or in any other investigational study at the same time.
  • Must not be randomized into the study more than once.
  • Subjects with the following clinical conditions/demography:
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  • Allergic to corticosteroids or beta-agonists.
  • Required hospitalization for asthma control within the previous 3 months.
  • Required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
  • Treated in the ER (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction, on 2 or more occasions within the last 6 months.
  • Clinical evidence of emphysema, chronic bronchitis, bronchiectasis, or cystic fibrosis.
  • Significant history of renal, hepatic, cardiovascular, metabolic, neurologic, hematological, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could have interfered with the study, or required treatment which might have interfered with the study.
  • Requiring the use of >12 puffs per day of Salbutamol on any 2 consecutive days between study visits.
  • Experienced upper or lower respiratory tract infection within the previous 2 weeks prior to enrollment.
  • Clinically relevant abnormal baseline vital sign.
  • Clinically significant abnormalities on chest x-ray at the Screening Visit or within the previous 6 months.
  • Evidence of clinically significant oropharyngeal candidiasis.
  • Smokers, or ex-smokers who are smoking or have smoked at least 20 years/pack or subjects who are smoking in the last 6 months.
  • Known to be HIV positive.
  • Known to be illicit drug abusers.
  • HPA axis disturbances.
  • Showing any clinical condition considered to be severe.
  • Severe airflow obstruction showing to be life-threatening.
  • Baseline FEV1 <55% of the predicted normal.
  • Uncontrolled hypertension.
  • Suspected pneumonia, pneumothorax, pneumomediastinum, pulmonary TB, alpha-1 anti-trypsin deficiency, lung mycosis or pulmonary cystic fibrosis.
  • History of thoracic surgery or any previous malignancy of the lung,
  • Significant heart disease,
  • Receiving beta-adrenergic blocking agents.
  • Presenting baseline portable peak expiratory flow at the Screening Visit <=50% of predicted. The best value out of 3 must be considered.

About this study

Official title: An Open-Label, Comparative, Randomized, Parallel, Multicenter Study to Determine the Efficacy and Safety of Two Dry Powder Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma

This is an open-label, comparative, randomized, parallel, multicenter study in asthmatics to determine whether the administration of dry powder inhaled mometasone furoate (MF) 400 μg in a monodose capsule device would be comparable to administration of powder inhaled MF 400 μg in a multidose device.

Conditions
Asthma
Being tested
MF
Medical subject headings
Asthma

What participants receive

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

  • MFDevice

    Also called Asmanex, SCH 32088

    One evening dose of dry powder inhaled MF 400 μg (Multidose device).

  • MFDevice

    Also called Asmanex, SCH 32088

    One evening dose of dry powder inhaled 400 μg (400 μg capsules - Monodose).

Study groups in NCT00817817
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Device: MF
Group 2ExperimentalNot described
Receives: Device: MF

What is being measured

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

  1. The assessment of efficacy will be done by spirometry, determining the difference in FEV1 and PEFR measured by spirometry on baseline, 7, 14, 28, 42 and 56 days after initiation of MF dry powder inhaler (DPI) therapy.

    Measured: Baseline, 7, 14, 28, 42, and 56 days after initiation of MF DPI therapy.

  2. To determine the number of puffs/day of rescue medication (Salbutamol).

    Measured: Daily

Secondary outcomes (6)

  1. To compare the PEFR daily measurements obtained by Peak flow Meter used by subjects at home.

    Measured: Daily

  2. To compare the daily scores for asthma symptoms and sleep quality.

    Measured: Every morning

  3. To compare the evaluation of response to therapy made by the investigator at each visit compared to the Baseline visit.

    Measured: Visits 2 to 6.

  4. To determine and compare the safety (HPA axis evaluation) of both treatments using 400 μg MF DPI once daily in adult subjects with asthma.

    Measured: Visits 2 to 6

  5. To determine and compare the safety (clinical laboratory measurements) of both treatments using 400 μg MF DPI once daily in adult subjects with asthma.

    Measured: Visit 6

  6. To determine and compare the tolerability (adverse events) of both treatments using 400 μg MF DPI once daily in adult subjects with asthma.

    Measured: Visits 2 to 6.

Timeline

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

  1. First posted7 Jan 2009 (estimated)
  2. Study start1 Oct 2002
  3. Primary completion1 May 2003
  4. Study completion1 May 2003

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00817817
Sponsor's protocol ID
P02524
Status last verified
Feb 2022
First submitted
6 Jan 2009
Last updated
15 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Pereira CA, Vianna FF, Cukier A, Stelmach R, Oliveira JC, Carvalho EV, Gomes EP, Mayo SV, Chibante AM, Domingues CP. Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients. J Bras Pneumol. 2010 Jul-Aug;36(4):410-6. doi: 10.1590/s1806-37132010000400004. English, Portuguese.

    PubMed 20835586

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MF in people with Asthma, 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 26 inclusion and 30 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 15 Aug 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The assessment of efficacy will be done by spirometry, determining the difference in FEV1 and PEFR measured by spirometry on baseline, 7, 14, 28, 42 and 56 days after initiation of MF dry powder inhaler (DPI) therapy. (time frame: Baseline, 7, 14, 28, 42, and 56 days after initiation of MF DPI therapy.). 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 NCT00817817, 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 15 Aug 2024.

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