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

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ClinicalTrials.gov Identifier: NCT01471340
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg Drug: Mometasone Furoate MDI 100 mcg Drug: Mometasone Furoate MDI 200 mcg Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI Drug: Prednisone/prednisolone Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 9, 2012
Primary Completion Date : November 30, 2016
Study Completion Date : November 30, 2016


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 Name: MK-0887A; Dulera/Zenhale
Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg
two inhalations BID
Other Name: 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: Mometasone Furoate MDI 100 mcg
two inhalations BID
Other Name: Asmanex
Drug: Mometasone Furoate MDI 200 mcg
two inhalations BID
Other Name: Asmanex
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471340


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01471340     History of Changes
Other Study ID Numbers: P06241
2011-002142-13 ( EudraCT Number )
MK-0887A-202 ( Other Identifier: Merck Protocol Number )
First Posted: November 16, 2011    Key Record Dates
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Mometasone Furoate
Prednisolone hemisuccinate
Prednisolone phosphate
Formoterol Fumarate
Albuterol
Mometasone Furoate, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Autonomic Agents