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

May 9, 2024 updated by: Organon and Co

A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

11744

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg
two inhalations BID
Other Names:
  • MK-0887A; Dulera/Zenhale
Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg
two inhalations BID
Other Names:
  • MK-0887A; Dulera/Zenhale
Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI
use as needed for asthma symptoms
Drug: Prednisone/prednisolone
Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator
Active Comparator: Mometasone Furoate MDI BID
MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments)
Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI
use as needed for asthma symptoms
Drug: Prednisone/prednisolone
Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator
Drug: Mometasone Furoate MDI 100 mcg
two inhalations BID
Other Names:
  • Asmanex
Drug: Mometasone Furoate MDI 200 mcg
two inhalations BID
Other Names:
  • Asmanex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
Time Frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.
26 weeks, or 7 days after the last treatment dose, whichever occurred later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
Time Frame: 26 weeks, plus 7 days after the last treatment
The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.
26 weeks, plus 7 days after the last treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SAO Components in MF/F Participants vs MF Participants
Time Frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only.
26 weeks, or 7 days after the last treatment dose, whichever occurred later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2012

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimated)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06241
  • 2011-002142-13 (EudraCT Number)
  • MK-0887A-202 (Other Identifier: Merck Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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