Who is sponsoring NCT01055041?

NCT01055041 is sponsored by Government Medical College, Bhavnagar.

What drugs are being tested in NCT01055041?

Interventions in NCT01055041: inhaled budesonide and formeterol plus oral montelukast, inhaled budesonide and formeterol plus oral doxophylline, Doubling the dose of inhaled budesonide and formeterol.

What condition does NCT01055041 study?

NCT01055041 studies Moderate to Severe Persistent Bronchial Asthma.

Is NCT01055041 still recruiting?

NCT01055041 is currently completed. Last updated 22 January 2010.

Last reviewed 2010-01-22 · How we verify

NCT01055041

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma

Completed NA Last updated 22 January 2010

What this trial tests

NA trial testing inhaled budesonide and formeterol plus oral montelukast in Moderate to Severe Persistent Bronchial Asthma in 50 participants. Completed in 1 July 2009.

Timeline

1 December 2008

Primary endpoint
1 June 2009

1 July 2009

Quick facts

Lead sponsor	Government Medical College, Bhavnagar
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 December 2008
Primary completion	1 June 2009
Estimated completion	1 July 2009
Sites	1 location across India

Drugs / interventions tested

inhaled budesonide and formeterol plus oral montelukast — full drug profile →
inhaled budesonide and formeterol plus oral doxophylline — full drug profile →
Doubling the dose of inhaled budesonide and formeterol — full drug profile →

Conditions studied

Moderate to Severe Persistent Bronchial Asthma — all drugs for Moderate to Severe Persistent Bronchial Asthma →

Sponsor

Government Medical College, Bhavnagar

Who can join

Adults 15 to 65, any sex, with Moderate to Severe Persistent Bronchial Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The primary outcome was percentage of improvement in FEV1
Time frame: 10 weeks

Sponsor's own description

The purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.
Chauhan BF, Ducharme FM. · · 2012 · cited 80× · PMID 22592685 · DOI 10.1002/14651858.cd002314.pub3

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01055041 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Government Medical College, Bhavnagar
Last refreshed: 22 January 2010

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01055041.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing