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Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Salbutamol sulfate/Ipratropium bromide (Drug); Salbutamol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

Official title: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)

Secondary outcome:

Change from baseline in systolic and diastolic blood pressure

Change from baseline in heart rate

Change from baseline in respiratory rate

Occurrence of adverse events

SaO2 (oxygen saturation) during metacholine challenge

Eligibility

Minimum age: 7 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: May 1998
Last updated: July 7, 2014

Page last updated: August 23, 2015

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