Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Asthma Clinical Trial

Official title:

Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182713
• Other study ID #: 1012.36
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2014
• Last updated: July 7, 2014
• Start date: May 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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 ß2 agonists: 6 hours

• Long acting ß2 agonists: 12 hours

• Ipratropium bromide: 8 hours

• DSCG (disodium cromoglicate): 7 days

• Nedocromil: 7 days

• ORAL:

• Short acting ß2 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

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Spasm

Intervention

Drug:
• Salbutamol sulfate/Ipratropium bromide
Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
• Salbutamol
Salbutamol 100 mcg per puff

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)		Baseline and 30 minutes after treatment	No
Secondary	Change from baseline in systolic and diastolic blood pressure		Baseline, 30 and 60 min after treatment	No
Secondary	Change from baseline in heart rate		Baseline, 30 and 60 min after treatment	No
Secondary	Change from baseline in respiratory rate		Baseline, 30 and 60 min after treatment	No
Secondary	Occurrence of adverse events		up to 8 days	No
Secondary	SaO2 (oxygen saturation) during metacholine challenge		continuously after adminstration of study drug	No

External Links

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