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

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg; Drug: Prednisone/prednisolone; Drug: Mometasone Furoate MDI 100 mcg; Drug: Mometasone Furoate MDI 200 mcg; Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI; Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471340

2011-002142-13 (EudraCT Number)

P06241

MK-0887A-202 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 11,744 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11,744 participants in 2 patient groups

Mometasone Furoate/Formoterol MDI BID

Experimental group

Description:

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

Treatment:

Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg

Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI

Drug: Prednisone/prednisolone

Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg

Mometasone Furoate MDI BID

Active Comparator group

Description:

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

Treatment:

Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI

Drug: Mometasone Furoate MDI 200 mcg

Drug: Prednisone/prednisolone

Drug: Mometasone Furoate MDI 100 mcg