A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)

NCT ID: NCT01471340

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11744 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-09
• Study Completion Date: 2016-11-30

Brief Summary

The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.

Detailed Description

Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mometasone Furoate/Formoterol MDI BID

MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments)

Group Type: EXPERIMENTAL

Mometasone Furoate/Formoterol MDI 100/5 mcg

Intervention Type: DRUG

two inhalations BID

Mometasone Furoate/Formoterol MDI 200/5 mcg

Intervention Type: DRUG

two inhalations BID

Albuterol 90 mcg /salbutamol 100 mcg HFA MDI

Intervention Type: DRUG

use as needed for asthma symptoms

Prednisone/prednisolone

Intervention Type: DRUG

Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Mometasone Furoate MDI BID

MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments)

Group Type: ACTIVE_COMPARATOR

Mometasone Furoate MDI 100 mcg

Intervention Type: DRUG

two inhalations BID

Mometasone Furoate MDI 200 mcg

Intervention Type: DRUG

two inhalations BID

Albuterol 90 mcg /salbutamol 100 mcg HFA MDI

Intervention Type: DRUG

use as needed for asthma symptoms

Prednisone/prednisolone

Intervention Type: DRUG

Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Interventions

Mometasone Furoate/Formoterol MDI 100/5 mcg

two inhalations BID

Intervention Type: DRUG

Mometasone Furoate/Formoterol MDI 200/5 mcg

two inhalations BID

Intervention Type: DRUG

Mometasone Furoate MDI 100 mcg

two inhalations BID

Intervention Type: DRUG

Mometasone Furoate MDI 200 mcg

two inhalations BID

Intervention Type: DRUG

Albuterol 90 mcg /salbutamol 100 mcg HFA MDI

use as needed for asthma symptoms

Intervention Type: DRUG

Prednisone/prednisolone

Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Intervention Type: DRUG

Other Intervention Names

MK-0887A; Dulera/Zenhale; MK-0887A; Dulera/Zenhale; Asmanex; Asmanex

Eligibility Criteria

Inclusion Criteria

• Persistent asthma for at least 1-year
• Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ICS) with or without a long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA) as a monotherapy.
• Must be able to discontinue current asthma medication
• Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks

Exclusion Criteria

• Unstable asthma
• Taking high dose ICS with or without other adjunctive therapy who have an Asthma Control Questionnaire 6 (ACQ6) total score ≥ 1.5
• Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score < 1.5 (controlled)
• Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other significant, non-asthmatic, lung disease
• Clinically significant abnormality, illness or disorder of any body or organ system
• Significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
• History of smoking greater than 10-pack years
• Had an asthma exacerbation within 4 weeks of the Baseline Visit
• Had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
• Known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
• Require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
• Requires the use of beta-blockers
• History of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
• Lactating, pregnant, or plans to become pregnant during the course of the trial

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Weinstein CLJ, Ryan N, Shekar T, Gates D, Lane SJ, Agache I, Nathan RA; SPIRO Investigators. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. 2019 Apr;143(4):1395-1402. doi: 10.1016/j.jaci.2018.10.065. Epub 2018 Dec 8.

Reference Type: RESULT

PMID: 30537475 (View on PubMed)

Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

Reference Type: DERIVED

PMID: 36472162 (View on PubMed)

Other Identifiers

2011-002142-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-0887A-202

Identifier Type: OTHER

Identifier Source: secondary_id

P06241

Identifier Type: -

Identifier Source: org_study_id