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AsthmaPhase 3NCT00975741

Efficacy and Safety of Two Dry Power Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma

A Phase 3 study testing OXIMAX and ASMANEX TWISTHALER in people with Asthma, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 5 sites in Brazil.

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

Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
OXIMAX and ASMANEX TWISTHALER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
5 sitesBrazil
Study dates
Oct 2002to Aug 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

  • A diagnosis of asthma for at least 6 months
  • Baseline FEV1 must be > = 55% and < = 85% of predicted
  • Increase in absolute FEV1 of >12%, with an absolute volume increase of at least 200 mL after reversibility testing
  • Use of an adequate form of birth control by non-pregnant women of childbearing potential
  • Absence of use of the following medication prior to the inclusion:
  • Beta 2 agonist short-acting (inhaled, oral)-12 Hours
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  • Beta 2 agonist long-acting (inhaled)-48 Hours
  • Ipratropium bromide-12 hours
  • Cromolyn sodium, nedocromil-07 days
  • Astemizole-03 months
  • Cetotifeno-03 months
  • Another investigational drug-01 month
  • Theophyline-2 weeks
  • Antihistamines-07 days
  • Anticholinergics-07 days
  • Leukotriene modifiers-2 weeks
  • Oral decongestant long-acting-72 hours
  • Oral decongestant short-acting-24 hours

Who cannot join

  • Women who were pregnant, breast-feeding, or are pre-menarcheal.
  • Subjects who have used any investigational drug within the last 30 days
  • Subjects who were receiving immunotherapy
  • Subjects requiring the use of >12 puffs per day of Salbutamol on any 2 consecutive days
  • Smokers or ex-smokers
  • Subjects who are allergic to corticosteroids or beta-agonists
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  • Subjects who have required inpatient hospitalization for asthma control within the previous 3 months
  • Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years
  • Subjects who have been treated in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction, on two or more occasions within the last six months
  • Subjects with clinical evidence of emphysema, chronic bronchitis, bronchiectasis, or cystic fibrosis
  • Subjects with a 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
  • Subjects who have experienced an upper or lower respiratory tract infection (viral or bacterial) within the previous 2 weeks prior to enrollment
  • Subjects who have clinically significant abnormalities on chest x-ray at the Screening Visit or within the previous year
  • Subjects who are known to be HIV positive
  • Subjects who are known to be illicit drug abusers
  • Subjects with hypothalamic-pituitary-adrenal (HPA) axis disturbances
  • Subjects with severe pulmonary airflow obstruction showing to be life-threatening characterized by cyanosis, confusion, somnolence, coma or tiredness, thorax silent to hearing or showing weak respiration,PEFR <25% of the predicted normal, bradycardia (heartbeats bellow 60 beats per minute)
  • Subjects with baseline FEV1 < 55% of the predicted normal
  • Subjects with uncontrolled hypertension
  • Subjects with suspected pneumonia, pneumothorax, pneumomediastinum, pulmonary tuberculosis, alpha-1 anti-trypsin deficiency, lung mycosis (blastomycosis, histoplasmic) or pulmonary cystic fibrosis
  • Subjects with history of thoracic surgery or any previous malignancy of the lung
  • Subjects with significant heart disease (e.g., previous acute myocardial infarction, angina pectoris, pulmonary edema or other cardiovascular disease which is characterized as life-threatening
  • Subjects receiving beta-adrenergic blocking agents

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Brazil5 sites

  • Hospital Universitário da Universidade Federal de Juíz de Fora

    Juíz de Fora, Minas Gerais

  • UNIRIO

    Rio de Janeiro, Rio de Janeiro

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo

  • Hospital do Servidor Público Estadual

    São Paulo, São Paulo

  • Hospital Heliópolis

    São Paulo, São Paulo

Other trials in Brazil

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

Mometasone furoate (MF) is a new potent synthetic corticosteroid. Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.

Read the detailed description

Background: Internationally, MF is administered by a breath-actuated DPI and supplied in multidose devices. Capsules to be administered through a monodose device that would offer an alternative to MF DPI multidose treatment in terms of cost-effectiveness were developed in Brazil. Results of laboratory analysis for respirable fraction, content uniformity of emitted dose and of the bulk powder and for percentage of particles < 1 micra of both MF 200 µg and MF 400 µg capsules have indicated their equivalent performance in comparison to MF DPI multidose.

Aim: The aim of the present non-inferiority clinical study was to evaluate both devices in terms of efficacy and safety.

Methods: Ninety-seven adult patients with moderate persistent asthma were randomized in two groups to receive for 60 days a dose of 400 µg of DPI MF once daily (at evening) using multidose or monodose device. Follow-up visits were scheduled at Days 7, 14, 28, 42 and 56. Efficacy was assessed by means of pulmonary function tests (spirometry - FEV1 and PEFR) at each visit. In addition, subjects have recorded twice daily PEFR, symptom scores and use of rescue medication throughout the study. Response to therapy was also assessed. Safety evaluations included monitoring of adverse events, vital signs, clinical laboratory tests (plasma cortisol concentrations were assessed at enrollment and repeated after 60 days of MF treatment; cortrosyn test was performed at the enrollment and after 60 days of MF treatment), and physical examination.

Conditions
Asthma
Being tested
OXIMAX, ASMANEX TWISTHALER
Keywords
Asthma, Mometasone furoate, Inhalation devices, Forced expiratory volume
Medical subject headings
Asthma

What participants receive

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

  • OXIMAXDevice

  • ASMANEX TWISTHALERDevice

Study groups in NCT00975741
Study groupRoleWhat they receive
Monodose deviceExperimentalMometasone furoate 400 µg DPI capsules administered through a monodose device.
Receives: Device: OXIMAX
Multidose deviceActive comparatorMometasone furoate 400 µg DPI capsules administered through a multidose device
Receives: Device: ASMANEX TWISTHALER

What is being measured

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

  1. Difference in Forced Expired Volume in one second (FEV1) and Peak Expiratory Flow Rate (PEFR) measured by spirometry; number of puffs/day of rescue medication (Salbutamol) used by the subjects.

    Measured: 56 days after initiation of therapy

Secondary outcomes (1)

  1. PEFR daily measurements, daily scores for asthma symptoms, response to therapy made by the Investigator, safety (hypothalamic-pituitary-adrenal axis evaluation and clinical laboratory measurements) and tolerability (adverse events).

    Measured: 56 days after initiation of therapy

Timeline

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

  1. First posted11 Sep 2009 (estimated)
  2. Study startOct 2002
  3. Study completionAug 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
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00975741
Sponsor's protocol ID
ASM/P/01/1
Status last verified
Sep 2009
First submitted
12 Aug 2009
Last updated
11 Sep 2009
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 OXIMAX and ASMANEX TWISTHALER in people with Asthma, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 5 sites in Brazil.

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 18 inclusion and 23 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 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. 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 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?

Difference in Forced Expired Volume in one second (FEV1) and Peak Expiratory Flow Rate (PEFR) measured by spirometry; number of puffs/day of rescue medication (Salbutamol) used by the subjects. (time frame: 56 days after initiation of therapy). 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 NCT00975741, 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 11 Sep 2009.

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