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Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

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ClinicalTrials.gov Identifier: NCT02182713
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.

Condition or disease Intervention/treatment Phase
Asthma Drug: Salbutamol sulfate/Ipratropium bromide Drug: Salbutamol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Study Start Date : May 1998
Actual Primary Completion Date : September 1998


Arm Intervention/treatment
Experimental: Arm 1 - CombiventTM followed by Salbutamol Drug: Salbutamol sulfate/Ipratropium bromide
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
Other Name: CombiventTM

Drug: Salbutamol
Salbutamol 100 mcg per puff
Other Name: Ventolin®

Active Comparator: Arm 2 - Salbutamol followed by CombiventTM Drug: Salbutamol sulfate/Ipratropium bromide
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
Other Name: CombiventTM

Drug: Salbutamol
Salbutamol 100 mcg per puff
Other Name: Ventolin®




Primary Outcome Measures :
  1. Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%) [ Time Frame: Baseline and 30 minutes after treatment ]

Secondary Outcome Measures :
  1. Change from baseline in systolic and diastolic blood pressure [ Time Frame: Baseline, 30 and 60 min after treatment ]
  2. Change from baseline in heart rate [ Time Frame: Baseline, 30 and 60 min after treatment ]
  3. Change from baseline in respiratory rate [ Time Frame: Baseline, 30 and 60 min after treatment ]
  4. Occurrence of adverse events [ Time Frame: up to 8 days ]
  5. SaO2 (oxygen saturation) during metacholine challenge [ Time Frame: continuously after adminstration of study drug ]


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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients with a diagnosis of asthma according to the American Thoracic Society Criteria
  • Patients aged 7 to 12 years inclusive
  • Patients able to perform spirometry
  • Patients with FEV1 (forced expiratory volume in the first second) ≥ 80% of predicted normal value after saline
  • Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml
  • Patients or responsible relatives willing and able to sign an informed consent form

Exclusion Criteria:

  • Patients on treatment for or suspected as having glaucoma
  • Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients
  • Patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum
  • Patients with a history of chest surgery
  • Patients with other respiratory conditions if diagnosed. These include pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS
  • Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen
  • Patients who have been previously recruited into this study
  • Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study
  • Patients with obvious or previously diagnosed serious hepatic or renal disease
  • Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge

    • INHALED:
    • Short acting β2 agonists: 6 hours
    • Long acting β2 agonists: 12 hours
    • Ipratropium bromide: 8 hours
    • DSCG (disodium cromoglicate): 7 days
    • Nedocromil: 7 days
    • ORAL:
    • Short acting β2 agonists: 18 hours
    • Anticholinergics: 7 days
    • Short acting theophylline: 24 hours
    • Long acting theophylline: 72 hours
    • Antihistamines: 7 days
    • Astemizole: 3 months
    • Ketotifen: 3 months
    • INHALED or ORAL: Other investigational drugs: 3 months
    • INHALED or ORAL: Corticosteroids: 30 days

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182713     History of Changes
Other Study ID Numbers: 1012.36
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Bromides
Albuterol
Ipratropium
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents