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A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01199289
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Condition or disease Intervention/treatment Phase
Asthma Drug: AMG 827 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma
Actual Study Start Date : October 4, 2010
Actual Primary Completion Date : December 21, 2011
Actual Study Completion Date : December 21, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: Placebo
SC injection.

Experimental: AMG 827 140 mg
Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: AMG 827
SC injection.

Experimental: AMG 827 210 mg
Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: AMG 827
SC injection.

Experimental: AMG 827 280 mg
Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: AMG 827
SC injection.




Primary Outcome Measures :
  1. Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12 [ Time Frame: Baseline and Week 12 ]

    The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment.

    It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1).

    The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.



Secondary Outcome Measures :
  1. Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline and Week 12 ]
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.

  2. Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12 [ Time Frame: Baseline and Week 12 ]
  3. Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12 [ Time Frame: Baseline to Week 12 ]
    Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.

  4. Change From Baseline in Daily Asthma Symptom Score to Week 12 [ Time Frame: Baseline and Week 12 ]

    Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation.

    Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21).

    Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.


  5. Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12 [ Time Frame: Baseline and Week 12 ]

    The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993).

    Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score = mean of the responses to the 32 questions.

    Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms.


  6. Proportion of Asthma Symptom-free Days [ Time Frame: Up to Week 12 ]

    Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use.

    The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks).


  7. Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10 [ Time Frame: Week 8 (days 60 and 64), and pre-dose on Week 10 ]
  8. Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10 [ Time Frame: Week 8 (days 60 and 64), and pre-dose on Week 10 ]
  9. Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10 [ Time Frame: Week 8 (days 60 and 64), and pre-dose on Week 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women 18 to 65 years of age
  • Percent of predicted FEV1 ≥ 50% and ≤ 80%
  • At least 12% reversibility over pre-bronchodilator FEV1
  • Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
  • Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion Criteria:

  • Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
  • History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
  • Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

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): NCT01199289


Locations
Show Show 49 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01199289    
Other Study ID Numbers: 20090203
First Posted: September 10, 2010    Key Record Dates
Results First Posted: November 26, 2021
Last Update Posted: November 26, 2021
Last Verified: October 2021
Keywords provided by Amgen:
Amgen
chronic inflammatory disease
wheezing
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Brodalumab
Dermatologic Agents