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

NCT00817817 | Completed Phase 3

• 1 other identifier: P02524
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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.

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

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

  Daily

Secondary Outcomes (6)

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

  Daily

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

  Every morning

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

  Visits 2 to 6.

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

  Visits 2 to 6

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

  Visit 6

Study Arms (2)

Group 1

EXPERIMENTAL

Device: MF

Group 2

EXPERIMENTAL

Device: MF

Interventions

MF DEVICE

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

Also known as: Asmanex, SCH 32088

Group 1

Eligibility Criteria

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

You may qualify if:

• 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 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.
• 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.
• 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)

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Organon and Co: lead

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 RESULT

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 Design

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

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: October 1, 2002
• Primary Completion: May 1, 2003
• Study Completion: May 1, 2003
• Last Updated: August 15, 2024

Record last verified: 2022-02