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Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(COMPLETED)
This study has been terminated.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00442351
  Purpose

This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) PM compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in FEV1 from Baseline to the end of treatment period (Week 12 or end of the study).


Condition Intervention Phase
Asthma
Drug: Asmanex Twisthaler
Phase IV

MedlinePlus related topics: Asthma
Drug Information available for: Mometasone furoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 Mcg QD PM Versus "Asmanex" Placebo QD PM

Further study details as provided by Schering-Plough:

Estimated Enrollment: 300
Study Start Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Must be 18-75 years of age, of either sex and any race.
  • Must have a diagnosis of asthma for >= 12 months.
  • Must be considered as having mild persistent or moderate persistent asthma.
  • Prior to Screening subjects must be using either low or moderate doses of an inhaled corticosteroid (ICS), with a short-acting beta-2 agonist (SABA) as needed (prn), or a SABA as necessary as monotherapy, for asthma control. Subjects who are using a combination ICS plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50, must be changed to treatment with fluticasone propionate (FLOVENT HFA 110 mcg twice daily [BID]) at least 30 days prior to the start of Run-In Period. Subjects who are using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period.
  • If the subject had been using a leukotriene receptor antagonist (LTRA), he/she must be off treatment with the LTRA for at least 14 days prior to the Baseline Visit.
  • Must have an FEV1 >= 65% but <= 85% of predicted normal value at Visit 1 (Screening Visit) and at Visit 3 (Baseline Visit) when SABAs have been withheld for at least 6 hours.
  • Must demonstrate an increase of absolute FEV1 of >= 12% with an absolute volume increase of at least 200 mL at the Screening Visit or have documentation of FEV1 reversibility of >= 12% within 2 years prior to the Screening Visit. FEV1 reversibility testing should be done after withholding inhaled SABA medication for at least 6 hours.
  • Subjects must have a frequency of asthma score of at least 3 (at least 2 symptoms); frequency of bronchodilator use score of at least 3 at the Screening Visit.
  • Must have a TASS of at least 6 on 8 or more of the 15 AM and PM recordings during the 7 day Run-in period and the AM of the Baseline Visit (Visit 3).
  • At the Screening Visit, subjects must complain of sleep disturbance and must have: a) a score of >= 2 on the interference with sleep rating scale (recall over the past 7 days/ >= 1 night) and b) a score at least 30 on the MOS-SS Sleep Disturbance Sleep Scale (recall over the past 7 days).
  • At the Baseline Visit, subjects must complain of sleep disturbance and must have: a) a score of >= 2 on interference with sleep rating scale (recorded in a diary during the 7 day Run-In Period/ >= 1 night) and b) a score of at least 30 on the MOS-SS Sleep Problems Index II (SLP 9) and at least 30 on the Daytime Somnolence Sleep Scale.

Exclusion Criteria:

  • Is a female who is pregnant, or intends to become pregnant during the study.
  • Is nursing, or intends to be nursing during the study or within 30 days after study completion.
  • Has participated in any clinical trial within the last 30 days or in a clinical trail that involved antibodies for asthma or rhinitis within 3 months prior to Randomization (Visit 3).
  • Has had an unscheduled physician or clinic visit (due to exacerbation of asthma) within 1 month prior to Randomization (Visit 3).
  • Has been treated in the emergency room or admitted to the hospital due to exacerbation of asthma on two or more occasions within the 12 months prior to Randomization (Visit 3).
  • Has used >12 puffs of rescue SABAs or 2 treatments with a nebulized beta-2-agonist per day on 2 consecutive days within 4 weeks prior to Randomization (Visit 3).
  • Required more than 2 courses of oral/systemic corticosteroids for asthma control within 12 months prior to Randomization (Visit 3).
  • Has a history of sleep disorders, including narcolepsy, insomnia, daytime somnolence, or use of medications that affect alertness or sleep.
  • Has sleep apnea, obstructive sleep apnea-hypopnea syndrome, or is being treated with CPAP or Bi-PAP, or is receiving oxygen by inhalation day or night.
  • Is allergic to corticosteroids, SABAs, or LABAs.
  • Required ventilator support for respiratory failure secondary to their asthma within the last 10 years.
  • Has symptomatic allergic rhinitis (total nasal and non-nasal symptom severity score >= 4) noted at the Screening and Baseline Visits (Visits 1, 2, and 3). (During any phase of the study, subjects who become symptomatic with allergic rhinitis can be treated with a nonsedating antihistamine and/or inhaled nasal corticosteroid. Allergic rhinitis severity should be rated and the score recorded in the diary at the initiation of this illness.

    • nasal signs/symptoms include nasal congestion/stuffiness, rhinorrhea, nasal itching, sneezing; non-nasal signs/symptoms include eye tearing, eye itching, eye redness, itching ears (palate); severity rating: 0 = none to 3 = severe
  • Has a Body-Mass-Index (BMI) greater than 35.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442351

Sponsors and Collaborators
Schering-Plough
Investigators
Principal Investigator: Steven Weinstein, MD Allergy & Asthma Specialists Medical Group in Huntington Beach, CA
  More Information

Study ID Numbers: P04654, IND Number: 46216; SCH 032088
Study First Received: February 28, 2007
Last Updated: August 22, 2007
ClinicalTrials.gov Identifier: NCT00442351  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mometasone furoate
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009