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

NCT00975741 | Completed Phase 3

• 1 other identifier: ASM/P/01/1
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 5

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

Conditions

Asthma

Keywords

Asthma; Mometasone furoate; Inhalation devices; Forced expiratory volume

Outcome Measures

Primary Outcomes (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.

  56 days after initiation of therapy

Secondary Outcomes (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).

  56 days after initiation of therapy

Study Arms (2)

Monodose device

EXPERIMENTAL

Mometasone furoate 400 µg DPI capsules administered through a monodose device.

Device: OXIMAX

Multidose device

ACTIVE COMPARATOR

Mometasone furoate 400 µg DPI capsules administered through a multidose device

Device: ASMANEX TWISTHALER

Interventions

OXIMAX DEVICE

Monodose device

ASMANEX TWISTHALER DEVICE

Multidose device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Beta 2 agonist short-acting (inhaled, oral)-12 Hours
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mantecorp Industria Quimica e Farmaceutica Ltd.: lead

Study Sites (5)

Hospital Universitário da Universidade Federal de Juíz de Fora

Juíz de Fora, Minas Gerais, Brazil

Location

UNIRIO

Rio de Janeiro, Rio de Janeiro, Brazil

Location

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

São Paulo, São Paulo, Brazil

Location

Hospital do Servidor Público Estadual

São Paulo, São Paulo, Brazil

Location

Hospital Heliópolis

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 20835586 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Carlos Alberto C Pereira, MD, PhD

  Hospital do Servidor Público Estadual, São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: September 11, 2009
• Study Start: October 1, 2002
• Study Completion: August 1, 2003
• Last Updated: September 11, 2009

Record last verified: 2009-09

Locations

BR (5)