ClinicalTrials.gg
CompletedNCT02182713Updated Jul 8, 2014

Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm

A Phase 4 interventional study of Salbutamol sulfate/Ipratropium bromide and Salbutamol in Asthma, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

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Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 72 studies testing albuterol in Asthma — 8 open to participants now, 9 under way, 1 of them phase 3. Albuterol · Asthma.

Enrollment
49th of 72
30 · median 63
Started
1998
with 1 other
Phase 4
25 of 72
2 open now
Registered
35th of 72
by date
Lead sponsor
2 of 72
Boehringer Ingelheim

Among the 72 studies testing albuterol in Asthma, this one is the 49th largest by enrollment, is one of 2 that started in 1998, is one of 25 in phase 4, and was the 35th registered.

Asthma

4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.

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Open to participants now

8 of the 72 studies testing albuterol in Asthma are open now, in 6 countries. Recruiting first, the newest first:

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By country, each count listing its studies:

All 8 open studies →

About albuterol

Albuterol: first FDA approval 1981 (PROVENTIL). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.

This study: 7 Years to 12 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Asthma

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04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 form

Exclusion criteria

Exclusion Criteria:

  • Patients on treatment for or suspected as having glaucoma
  • Patients with known allergy of to either salbutamol, ipratropium or their
  • 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 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 drugs: 3 months
    • INHALED or ORAL: : 30 days
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Arm 1 - CombiventTM followed by Salbutamol

    Drug: Salbutamol sulfate/Ipratropium bromide · Drug: Salbutamol

  • Active comparator
    Arm 2 - Salbutamol followed by CombiventTM

    Drug: Salbutamol sulfate/Ipratropium bromide · Drug: Salbutamol

Interventions

  • DrugSalbutamol sulfate/Ipratropium bromide

    Drug pages: Albuterol · Ipratropium

    Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff

    Also known as: CombiventTM

  • Salbutamol 100 mcg per puff

    Also known as: Ventolin®

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 1998 and a primary completion of Sep 1998. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2014
First posted
Jul 8, 2014
Start
May 1998
Primary completionActual
Sep 1998
Last update
Jul 8, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02182713
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
May 1998
Primary completion
Sep 1998
Last update
Jul 8, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Albuterol · Ipratropium

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