A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3) (SPIRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01471340
First received: November 10, 2011
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Time-to-first serious asthma outcomes (a composite endpoint defined as asthma-related: hospitalizations, intubations, and deaths) [ Time Frame: Baseline up to 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time-to-first asthma exacerbation [ Time Frame: Baseline up to 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 11664
Study Start Date: January 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mometasone Furoate/Formoterol MDI 200/10 mcg
MF/F MDI 200/10 mcg twice daily (BID)
Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg
two inhalations twice daily (BID)
Other Name: SCH 418131 (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
Experimental: Mometasone Furoate/Formoterol MDI 400/10 mcg
MF/F MDI 400/10 mcg BID
Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg
two inhalations BID
Other Name: SCH 418131 (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 200 mcg
MF MDI 200 mcg BID
Drug: Mometasone Furoate MDI 100 mcg
two inhalations BID
Other Name: SCH 032088
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 400 mcg
MF MDI 400 mcg BID
Drug: Mometasone Furoate MDI 200 mcg
two inhalations BID
Other Name: SCH 032088
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471340

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 154 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01471340     History of Changes
Other Study ID Numbers: P06241, 2011-002142-13, MK-0887A-202
Study First Received: November 10, 2011
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014