Effectiveness and Cost Study Comparing Two Ways to Deliver Albuterol for the Treatment of Asthma in the Hospital
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Study type: Interventional

Summary: 
      This study will be conducted as a randomized, double blinded, controlled trial. The control
      group will receive albuterol delivered by a nebulizer along with placebo treatments delivered
      by a metered dose inhaler (MDI) with a spacer +/- mask. The experimental group will receive
      albuterol delivered by MDI with spacer +/- mask along with placebo treatments given by a
      nebulizer. Parents, participants, study personnel, nursing staff, and respiratory therapists
      will not know the treatment assignments of participants. The primary outcome will be changes
      over time in an asthma severity score, the Clinical Asthma Score (CAS) (Parkin et al. 1996).
      The secondary outcomes will be total number of albuterol treatments received in the hospital,
      time it take to give treatments, time till subjects' albuterol treatments are given at four
      hour intervals, and the costs of the two types of treatments. The study hypothesis is that
      albuterol delivered by metered dose inhaler with spacer is non-inferior to albuterol
      delivered by nebulizer in the treatment of children hospitalized with moderate to severe
      asthma exacerbations.
    

Detailed description: 
      Studies looking at the use of beta-2-agonists given by MDIs with a spacer and mask in
      children greater than 2 years have described fewer side effects than when the same
      medications are given as nebulizers. Patients have less tachycardia, vomiting, and oxygen
      desaturation (Kerem et al. 1993, Chou, Cunningham and Crain 1995, Lin and Hsieh 1995,
      Pendergast et al. 1989, Fuglsang and Pedersen 1986).

      In the emergency department setting, Rubilar et. al found that albuterol delivered by MDI
      with spacer and mask had equal efficacy to albuterol delivered by a nebulizer in treating
      acute wheezing in children less than 2 years of age. (Rubilar, Castro-Rodriguez and Girardi
      2000) Chou et. al found that in children greater than 2 years old with acute asthma
      exacerbations, MDIs had the same efficacy as nebulizers but with a shorter delivery time and
      fewer side effects.(Chou et al. 1995)

      All children who meet criteria to be participants in the study will be approached for
      possible study enrollment in the ED. No outside recruiting will be done. Once consent has
      been obtained and patients are enrolled, they will be randomized to either albuterol by MDI
      with placebo nebulizer treatments or albuterol by nebulizer with placebo MDI treatments.
      Subjects will be randomized to one of the two treatment arms in a 1:1 randomization process.
      This will be done using a prepared assignment log developed using a random number generator.

      Children in the control arm will receive albuterol via nebulizer and placebo by MDI with
      spacer +/- mask. Children in the experimental arm will receive albuterol by MDI and placebo
      by nebulizer.

      All MDI treatments will be given with a spacer +/- mask. Subjects will receive 6 puffs if
      they are < 30 kg and 10 puffs if they are > 30 kg. If they are in the control group, puffs
      will be placebo. If they are in the experimental group, puffs will be albuterol (90
      micrograms per puff).

      For the nebulizer treatments, patients in the control group will receive 2.5 mg albuterol (if
      <30 kg) or 5 mg of albuterol (if 30 kg or greater) in 3 ml of normal saline. Patients in the
      experimental group will receive nebulizer treatments as 3 ml of normal saline. Nebulized
      treatments will be delivered with room air unless the subjects are on oxygen.

      All study medication will be administered by clinical nursing staff or respiratory
      therapists. The frequency at which albuterol is given will be determined by the subject's
      primary medical team. For all subjects, MDI treatments will be given first followed by
      nebulizer treatments.

      Nursing staff will record a Clinical Asthma Score (CAS) (Parkin et. al 1996) on admission and
      every 4 hours during hospitalization up to 72 hours or discharge (whichever comes first).
      Nursing staff will also record the total number of albuterol treatments given and the time
      required to give each treatment. Patients' total length of stay will be calculated. A cost
      analysis will be done to determine if there are any differences in the costs to the hospital
      of the two delivery devices. This analysis will include the costs of the albuterol and
      delivery devices and the labor costs related to nursing or respiratory therapists' time to
      administer the medications. Information on subjects' baseline level of asthma severity will
      also be collected at the beginning of the study.

      All study patients will be given prednisolone, prednisone or solumedrol at a dose of 1
      mg/kg/dose twice a day for a total of 5 days. The length of steroid treatment can be extended
      beyond 5 days if felt to be clinically indicated by the subject's attending physician.

      Controller medications such as long acting beta-2-agonists, inhaled corticosteroids, and
      leukotriene inhibitors will be given at the discretion of the subject's in patient attending.
      All controller medications used before and during hospitalization will be recorded as part of
      the study data.
    

Intervention name(s): Metered Dose Inhaler & Optichamber Advantage Valve Holding Chamber (VHC); Airlife Sidestream High Efficiency Nebulizer
Intervention type(s): Device; Device
Intervention description(s): Albuterol is delivered by metered dose inhaler with valved holding chamber. For children less than 6 years of age, a mask is also used.; Albuterol is delivered as a mist mixed with normal saline using a nebulizer machine and face mask or mouth piece.
Intervention MeSH terms: Imidacloprid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metered Dose Inhalers; Nebulizers; Randomized Controlled Trial