Two Inhalation Methods Using a Pressurized Metered Dose Inhaler With Valved Holding Chamber to Assess Improvement in Lung Function After SABA Administration in Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible
      episodes of breathlessness, wheezing, chest tightness and/ or cough. The prevalence of asthma
      in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of
      asthma is made in the presence of clinical symptoms with or without reversibility on
      spirometry assessment.1 Treatment comprises of inhaled medications that are used either as
      controller medication or a reliever medications.

      In a recent study involving asthmatic children, single maximal inhalation with breath hold
      was not found to be superior to tidal breathing for improvement in peak expiratory flow
      rates.

      The authors hypothesized that both the techniques would improve FEV1 similarly.
    

Detailed description: 
      Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible
      episodes of breathlessness, wheezing, chest tightness and/ or cough.1 The prevalence of
      asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis
      of asthma is made in the presence of clinical symptoms with or without reversibility on
      spirometry assessment.1 Treatment comprises of inhaled medications that are used either as
      controller medication or a reliever medications.1 PEF measurements are known to be affected
      by the technique and the equipment by which it is measured, and thus proper instructions and
      training are essential for the patient.1 PEF measurements have been used in the past as a
      surrogate to FEV1 measurements, but the correlation between them is poor and hence they
      should not be used interchangeably. If PEF falls below 80% of personal best, it is suggestive
      of inadequate disease control.1 Inhaled medications are delivered through various device
      either as dry powder forms or in a pressurized meter dose inhaler (pMDI). However, the drug
      delivery is variable and a pMDI delivers only 10-20% of the nominal dose per actuation or
      puff, even when used correctly.2,3 Use of spacer improves the drug delivery and the recent
      Indian guidelines recommends use of pMDI with a spacer as an effective drug delivery system.
      Tidal breathing with a pMDI with spacer is as effective as the single breath method as per
      the British/Scottish Intercollegiate Guidelines Network (SIGN) recommendations.4
      Breath-holding is usually recommended after the aerosol inhalation, but there is limited
      information on the clinical importance of breath-holding in adult asthmatic patients. In a
      recent study involving asthmatic children, single maximal inhalation with breath hold was not
      found to be superior to tidal breathing for improvement in peak expiratory flow rates.5
      Information on comparative efficacy of either method is limited in adult asthmatics. The
      authors hypothesized that both the techniques would improve FEV1 similarly. Thus, the
      objective of the present study is to assess improvement in lung function (FEV1) after
      short-acting beta-2 agonist administration in treatment-naïve adult patients with bronchial
      asthma with a single maximal inhalation with breath-hold versus 5 tidal breaths during
      inhalation using a valved holding chamber.
    

Intervention name(s): Single Inhalation technique; Tidal inhalation technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Single maximal inhalation with breath hold technique; 5 tidal breaths technique
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All the patients will receive inhaled salbutamol using two techniques during lung function testing on two successive days. Patient will be randomized 1:1 to receive inhaled salbutamol by performing either a single breath holding maneuver or by five tidal breaths on the first day of evaluation. Each patient will undergo spirometry using the other alternative procedure on the next day. The randomization sequence will be computer generated. The sequence generated will be kept in a sealed opaque envelope and will be opened at the time of procedure
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other