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OpenTrials
Completed

NCT Number: NCT01360021

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Rousse, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 12 years and above
  • Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
  • Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
  • Patients with reversible airway obstruction
  • Documented daily use of inhaled corticosteroids for ≥ 3 months

Exclusion criteria

  • History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
  • Hospitalized during previous 6 months for asthma
  • Required emergency treatment more than once during previous 6 months for an asthma-related condition
  • Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
  • Respiratory infection affecting the asthma within 30 days

Treatment and study plan

Symbicort

Drug

Breath actuated metered dose inhaler

Budesonide

Drug

Actuation counter pressured metered dose inhaler

Primary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1) - Post Dose

    Time frame: 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg

    Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.

  2. Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose

    Time frame: Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg

    Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.

Secondary outcomes

  1. Peak Expiratory Flow

    Time frame: Recorded morning upon rising and evening before sleep for 14 weeks

  2. Asthma Symptoms Score (Total)

    Time frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks

    The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.

  3. Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)

    Time frame: Recorded 6:00 - 11:00 AM for 14 weeks

    The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.

  4. Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)

    Time frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks

    Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics

Acronym: BAI

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 25, 2011
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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